CClinicalTrials.gg
Status unknownNCT05180266Updated Jan 6, 2022

Therapeutic Touch and Music in The Menopausal Period

An interventional study of Therapeutic Touch and Music Listening Group in Menopause, sponsored by Inonu University. Status unknown at 1 site in Turkey. Open to female participants aged 45 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-06.

Sponsored by Inonu University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
45 Years to 59 Years
Sex
Female
01

Study summary

Menopause is a natural phenomenon and physiological process in middle-aged women. It is noted that women most often complain of vasomotor symptoms and sleep disorders during the menopausal period, and therefore their quality of daily life is negatively affected. Reduce symptoms and improve quality of life for menopausal women they are applying for medical approaches due to the side effects of the method compared to music, yoga, aromatherapy, therapeutic massage, physical exercise, sleep hygiene education, therapeutic touch, acupressure, acupuncture and cognitive behavioral therapy as a non pharmacological methods, it is observed that they resort to such methods. Therefore, the aim of this study is to investigate the effect of therapeutic touch and music listening on sleep quality, menopausal symptoms and quality of life in menopausal women. Therefore, the aim of this study is to investigate the effect of therapeutic touch and music listening on sleep quality, menopausal symptoms and quality of life in menopausal women.

Read the detailed description

Menopause is a long period of life characterized by the permanent termination of the menstrual cycle due to the cessation of ovarian functions. It is the most important midlife crisis in which special physical and psychological differences occur, often associated with a decrease in estrogen levels. Although the natural age of menopause varies, it usually ranges from 40 to 58 years, and the average age of menopause is accepted as 51. When the average life expectancy of women is accepted as 80 years, women spend about a third or more of their life in the postmenopausal period.

Along with the decrease in estrogen during menopause, symptoms related to hot flashes, night sweats, palpitations, irritability and sleep disorders are common. Especially sleep disorders are higher than in the premenopausal period. It has been reported that approximately 40-60% of menopausal women have sleep-related symptoms with night awakenings as the most common complaint. In the study of Lima et al. in which they included 819 climacteric women in Brazil; Deterioration in sleep quality was detected in 67% of the sample, more prominently in postmenopausal women. The most common complaints during menopause are deterioration of sleep quality and chronic insomnia. Untreated sleep disorders and menopausal symptoms adversely affect health and especially reduce quality of life. When the literature is examined, poor sleep quality and insufficient sleep duration; hormonal changes, poor physical health, obesity, cardiovascular disease, diabetes, irritability, physical and mental burnout, and poor quality of life, such as short-term and long-term outcomes. It is stated that the symptoms seen in the menopausal period negatively affect the quality of life of women.

Although the effective treatment to be used to solve the sleep problems experienced during the menopause period, reduce the menopausal symptoms and improve the quality of life is medication or hormonal therapy, the use of non-pharmacological methods is increasing due to the potential side effects of these treatments and the harm outweighing the benefit. Some of these methods are music, yoga, aromatherapy, therapeutic massage, physical exercise, sleep hygiene education, therapeutic touch, acupressure, acupuncture and cognitive behavioral therapy methods.

Therapeutic touch, which is among the non-pharmacological methods that have started to be preferred in recent years, is the interpretation of an ancient healing experience in the modern age. It is a non-invasive nursing intervention that channels energy using the hands. There are no known side effects associated with the use of therapeutic touch. Therapeutic touch is beneficial in reducing anxiety, pain and depression, and increasing relaxation and well-being.Therefore, this calming effect of therapeutic touch also facilitates falling asleep and can improve quality of life by easing menopausal symptoms. Another widely used non-pharmacological method is recital. Perceived calming music lowers catecholamine levels, respiratory rate, heart rate, and blood pressure. Therefore, by roviding physiological and psychological relaxation, music helps individuals to sleep better, reduce menopausal symptoms, and improve quality of life. In a meta analysis study, it was determined that listening to calming music effectively improved sleep quality.

When the literature was examined, no study was found that examined the effects of therapeutic touch and music listening on sleep quality, menopausal symptoms and menopausal quality of life in menopausal women. It is thought that the findings obtained from the research will contribute to the literature. Based on all these, the aim of this study is to examine the effects of therapeutic touch and music listening on sleep quality, menopausal symptoms and quality of life in menopausal women.

Purpose Of The Study The aim of the study was to investigate the effect of therapeutic touch and music listening on sleep quality, menopausal symptoms and quality of life in menopausal women.

Research Hypotheses H10: Therapeutic touch does not affect sleep quality in menopausal women H11: Therapeutic touch affects sleep quality in menopausal women H20: Therapeutic touch does not affect menopausal symptoms in menopausal women H21: Therapeutic touch affects menopausal symptoms in menopausal women H30: Therapeutic touch does not affect quality of life in menopausal women H31: Therapeutic touch affects quality of life in menopausal women H40: Music listening does not affect sleep quality in menopausal women H41: Listening to music affects sleep quality in menopausal women H50: Listening to music does not affect menopausal symptoms in menopausal women H51: Listening to music affects menopausal symptoms in menopausal women H60: Music listening does not affect quality of life in menopausal women H61: Music listening affects quality of life in menopausal women

02

Conditions studied

  • Menopause

Keywords

  • Menopausal Symptoms
  • Sleep Quality
  • Therapeutic Touch
  • Music listening
03

In context

Lead sponsor

Inonu University is the lead sponsor of 375 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 59 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • between the ages of 45-59
  • Not taking Hormone Replacement Therapy,
  • No psychiatric history,
  • Women who do not use any other CAM methods will be included in the study.

Exclusion criteria

Exclusion Criteria:

  • Those who are in surgical menopause,
  • Having auditory problems that prevent listening to music,
  • Using any other TAT method,
  • Women who use drugs that affect sleep (using antidepressant, antihistamine, benzodiazepan, hypnotic and narcotic drugs) will be excluded from the study.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Care provider)
Enrollment
108 participants (estimated)

Study arms

  • Experimental
    Therapeutic Touch Group

    In order to examine the effects of therapeutic touch on menopausal symptoms, sleep and quality of life, women will be given therapeutic touch for 15 minutes, once a week for four weeks.Therapeutic touchis a form of descriptive treatment that lasts approximately 15-20 minutes, in which hands are used on or near the body to correct abnormalities in the person's energy field and to achieve healing, and the energy in the universe is transferred from the practitioner's hands to the applied individual.

    Other: Therapeutic Touch

  • Experimental
    Music Listening Group

    The women were asked to listen to the relaxation music included in the relaxation exercises CD prepared by the Turkish Psychological Association every day for four weeks in a comfortable environment at home for 30 minutes before bedtime.

    Other: Music Listening Group

  • Other
    Control Group

    No action will be taken on the control group for four weeks.

    Other: Control Group

Interventions

  • OtherTherapeutic Touch

    Each of the women will be informed about the purpose and content of the study at the first meeting, and informed consent will be obtained from the women who meet the conditions for participation and agree to participate. The pre-test data in the research will be obtained with the Participant Identification Form, PSQI,MRS and MENQOL. After pre-test data collection, women will be given an appointment for therapeutic administration.The therapeutic touch group will be applied to the therapeutic touch group once a week for four weeks in a suitable room in the Faculty of Nursing and on the specified day and time by the researcher.At the end of the fourth week, post-test data will be obtained by filling in PSQI, MRS and MENQOL again.

  • OtherMusic Listening Group

    Each of the women was informed about the purpose and content of the study at the first meeting, and informed consent was obtained from the women who met the conditions for participation and accepted to participate.The pre-test data in the research will be obtained with the Participant Identification Form, PSQI, MRS and MENQOL. Music stream, music will be uploaded to mobile phones. He will be asked to listen to music (relaxation music in the relaxation exercises CD prepared by the Turkish Psychological Association) for 30 minutes before going to sleep every day for four weeks. At the end of the fourth week, post-test data will be obtained by filling in PSQI, MRS and MENQOL again

  • OtherControl Group

    Each of the women will be informed about the purpose and content of the study at the first meeting, and informed consent will be obtained from the women who meet the conditions for participation and agree to participate.The pre-test data in the research will be obtained with the Participant Identification Form, PSQI, MRS and MENQOL. No action will be taken on the control group for four weeks. At the end of the fourth week, post-test data will be obtained by filling in PSQI, MRS and MENQOL again.

06

What researchers measure

Primary outcomes

  1. The effect of therapeutic touch on sleep quality

    Pittsburgh Sleep Quality Index: The index consists of a total of 24 questions and 7 components. The sum of the scores from the seven components gives the total Pittsburgh Sleep Quality Index score. The total Pittsburgh Sleep Quality Index score can take a value between 0-21. The sleep quality of individuals with a total Pittsburgh Sleep Quality Index score of 5 or less was "good"; The sleep quality of individuals with a score above 5 points is evaluated as "poor". Pre-test data in the research will be obtained with the Menopause Symptoms Rating Scale. After completing the scale, women will receive therapeutic touch once a week for four weeks. At the end of the fourth week, the Menopause Symptoms Rating Scale will be filled again.

    Time frame: eleven months

  2. The effect of therapeutic touch on menopausal symptoms

    Menopause Symptoms Rating Scale : There are a total of 11 questions on the Likert-type scale, including menopausal complaints. Each question is scored from 0 to 4. While the minimum score that can be taken from the scale is 0, the maximum score is 44. The increase in the total score obtained from the scale shows the increase in the severity of the complaints, while at the same time it shows that the quality of life is negatively affected. Pre-test data in the research will be obtained with the Menopause Symptoms Rating Scale. After completing the scale, women will receive therapeutic touch once a week for four weeks. At the end of the fourth week, the Menopause Symptoms Rating Scale will be filled again.

    Time frame: eleven months

  3. The effect of therapeutic touch on quality of life

    Menopause-Specific Quality of Life Scale: The validity and reliability of the scale was determined by Kharbouch and Şahin in 2007 by adapting the scale to Turkish society Menopause-Specific Quality of Life Scale is a 29-item Likert-type scale. Each question score is ranked from 0 to 6. A score of 0 indicates that women do not have any problems with that subject. A score of 1 indicates that there is a problem with that subject, it is experienced, but it is not disturbing at all. Scores between 2 and 6 indicate the severity and increasing degrees of the existing problem. An increase in the scale score indicates an increase in the severity of the complaints. Pre-test data in the research will be obtained with the Menopause Specific Quality of Life Scale. After completing the scale, women will receive therapeutic touch once a week for four weeks. At the end of the fourth week, the Menopause-Specific quality of life scale will be filled again.

    Time frame: eleven months

  4. The effect of listening to music on sleep quality

    Pittsburgh Sleep Quality Index: The index consists of a total of 24 questions and 7 components. The sum of the scores from the seven components gives the total Pittsburgh Sleep Quality Index score. The total Pittsburgh Sleep Quality Index score can take a value between 0-21. The sleep quality of individuals with a total Pittsburgh Sleep Quality Index score of 5 or less was "good"; The sleep quality of individuals with a score above 5 points is evaluated as "poor". Pre-test data in the study will be obtained with the Pittsburgh Sleep Quality Index. After the scale is filled, relaxation music will be sent to the women's phones. He will be asked to listen to this music for 30 minutes before going to sleep for four weeks. At the end of the fourth week, the Pittsburgh Sleep Quality Index will be administered again.

    Time frame: eleven months

  5. The effect of listening to music on menopausal symptoms

    Menopause Symptoms Rating Scale : The Turkish validity and reliability study of the scale was carried out by Gürkan in 2005. There are a total of 11 questions on the Likert-type scale, including menopausal complaints. Each question is scored from 0 to 4. While the minimum score that can be taken from the scale is 0, the maximum score is 44. The increase in the total score obtained from the scale shows the increase in the severity of the complaints, while at the same time it shows that the quality of life is negatively affected. Pre-test data in the study will be obtained with the Menopause Symptoms Rating Scale. After the scale is filled, relaxation music will be sent to the women's phones. He will be asked to listen to this music for 30 minutes before going to sleep for four weeks. At the end of the fourth week, the Menopause Symptoms Rating Scale will be administered again.

    Time frame: eleven months

  6. The effect of listening to music on quality of life

    Menopause-Specific Quality of Life Scale: Menopause-Specific Quality of Life Scale is a 29-item Likert-type scale. Each question score is ranked from 0 to 6. A score of 0 indicates that women do not have any problems with that subject. A score of 1 indicates that there is a problem with that subject, it is experienced, but it is not disturbing at all. Scores between 2 and 6 indicate the severity and increasing degrees of the existing problem. An increase in the scale score indicates an increase in the severity of the complaints. Pre-test data in the study will be obtained with the Menopause-Specific Quality of Life Scale. After the scale is filled, relaxation music will be sent to the women's phones. He will be asked to listen to this music for 30 minutes before going to sleep for four weeks. At the end of the fourth week, the Menopause-Specific Quality of Life Scale will be administered again.

    Time frame: eleven months

07

Study locations

1 of 1 sites recruiting
  • Inonu University
    Malatya, 44000, Turkey
    Recruiting
08

References and documents

Publications

  • Abedian Z, Eskandari L, Abdi H, Ebrahimzadeh S. The Effect of Acupressure on Sleep Quality in Menopausal Women: A Randomized Control Trial. Iran J Med Sci. 2015 Jul;40(4):328-34. PubMed 26170519 ↗
  • Marlatt KL, Beyl RA, Redman LM. A qualitative assessment of health behaviors and experiences during menopause: A cross-sectional, observational study. Maturitas. 2018 Oct;116:36-42. doi: 10.1016/j.maturitas.2018.07.014. Epub 2018 Jul 21. PubMed 30244777 ↗
  • Kamalifard M, Farshbaf-Khalili A, Namadian M, Ranjbar Y, Herizchi S. Comparison of the effect of lavender and bitter orange on sleep quality in postmenopausal women: A triple-blind, randomized, controlled clinical trial. Women Health. 2018 Sep;58(8):851-865. doi: 10.1080/03630242.2017.1353575. Epub 2017 Aug 25. PubMed 28749734 ↗
  • Adimi Naghan P, Hassani S, Sadr M, Malekmohammad M, Khoundabi B, Setareh J, Seyedmehdi SM, Seifi S. Sleep Disorders and Mental Health in Menopausal Women in Tehran. Tanaffos. 2020 Jan;19(1):31-37. PubMed 33101429 ↗
  • Xu Q, Lang CP. Examining the relationship between subjective sleep disturbance and menopause: a systematic review and meta-analysis. Menopause. 2014 Dec;21(12):1301-18. doi: 10.1097/GME.0000000000000240. PubMed 24800878 ↗
  • Moudi A, Dashtgard A, Salehiniya H, Sadat Katebi M, Reza Razmara M, Reza Jani M. The relationship between health-promoting lifestyle and sleep quality in postmenopausal women. Biomedicine (Taipei). 2018 Jun;8(2):11. doi: 10.1051/bmdcn/2018080211. Epub 2018 May 28. PubMed 29806589 ↗
  • Cintron D, Lipford M, Larrea-Mantilla L, Spencer-Bonilla G, Lloyd R, Gionfriddo MR, Gunjal S, Farrell AM, Miller VM, Murad MH. Efficacy of menopausal hormone therapy on sleep quality: systematic review and meta-analysis. Endocrine. 2017 Mar;55(3):702-711. doi: 10.1007/s12020-016-1072-9. Epub 2016 Aug 11. PubMed 27515805 ↗
  • Cao Y, Yin X, Soto-Aguilar F, Liu Y, Yin P, Wu J, Zhu B, Li W, Lao L, Xu S. Effect of acupuncture on insomnia following stroke: study protocol for a randomized controlled trial. Trials. 2016 Nov 16;17(1):546. doi: 10.1186/s13063-016-1670-0. PubMed 27852282 ↗
  • Lima AM, Rocha JSB, Reis VMCP, Silveira MF, Caldeira AP, Freitas RF, Popoff DAV. [Loss of quality of sleep and associated factors among menopausal women]. Cien Saude Colet. 2019 Jul 22;24(7):2667-2678. doi: 10.1590/1413-81232018247.19522017. Portuguese. PubMed 31340284 ↗
  • Attarian H, Hachul H, Guttuso T, Phillips B. Treatment of chronic insomnia disorder in menopause: evaluation of literature. Menopause. 2015 Jun;22(6):674-84. doi: 10.1097/GME.0000000000000348. PubMed 25349958 ↗
  • Crivello, A., Barsocchi, P., Girolami, M., & Palumbo, F. (2019). The meaning of sleep quality: a survey of available technologies. IEEE access, 7, 167374-167390.
  • Troynikov O, Watson CG, Nawaz N. Sleep environments and sleep physiology: A review. J Therm Biol. 2018 Dec;78:192-203. doi: 10.1016/j.jtherbio.2018.09.012. Epub 2018 Oct 5. PubMed 30509635 ↗
  • Hachul, H., & Polesel, D. N. (2017). Insomnia pharmacotherapy: a review of current treatment options for insomnia in menopause. Current sleep medicine reports, 3(4), 299-305.
  • Afonso RF, Hachul H, Kozasa EH, Oliveira Dde S, Goto V, Rodrigues D, Tufik S, Leite JR. Yoga decreases insomnia in postmenopausal women: a randomized clinical trial. Menopause. 2012 Feb;19(2):186-93. doi: 10.1097/gme.0b013e318228225f. PubMed 22048261 ↗
  • Johnson A, Roberts L, Elkins G. Complementary and Alternative Medicine for Menopause. J Evid Based Integr Med. 2019 Jan-Dec;24:2515690X19829380. doi: 10.1177/2515690X19829380. PubMed 30868921 ↗
  • HÖzcan, H., Çakmak, S., & Salman, E. (2020). Complementary and Alternative Medicine Methods Used for Sleep Disturbance in Menopause. Journal of Turkish Sleep Medicine, 3, 207-213.
  • Vardar, O., Özkan, S., & Sercekus, P. (2020). Postmenopozal kadınlarda uygulanan egzersiz programının uyku kalitesine etkisi. Cukurova Medical Journal, 45(3), 1108-1114.
  • j. V. Dall, "Promoting sleep with therapeutic touch," Addict. Nurs. Netw., vol. 5, no. 1, pp. 23-24, 1993.
  • Tabatabaee A, Tafreshi MZ, Rassouli M, Aledavood SA, AlaviMajd H, Farahmand SK. Effect of Therapeutic Touch in Patients with Cancer: a Literature Review. Med Arch. 2016 Apr;70(2):142-7. doi: 10.5455/medarh.2016.70.142-147. Epub 2016 Apr 1. PubMed 27194823 ↗
  • Cordi MJ, Ackermann S, Rasch B. Effects of Relaxing Music on Healthy Sleep. Sci Rep. 2019 Jun 24;9(1):9079. doi: 10.1038/s41598-019-45608-y. PubMed 31235748 ↗
  • Liu YH, Lee CS, Yu CH, Chen CH. Effects of music listening on stress, anxiety, and sleep quality for sleep-disturbed pregnant women. Women Health. 2016;56(3):296-311. doi: 10.1080/03630242.2015.1088116. Epub 2015 Sep 11. PubMed 26361642 ↗
  • Dickson GT, Schubert E. How does music aid sleep? literature review. Sleep Med. 2019 Nov;63:142-150. doi: 10.1016/j.sleep.2019.05.016. Epub 2019 Jun 8. PubMed 31655374 ↗
  • Chen CT, Tung HH, Fang CJ, Wang JL, Ko NY, Chang YJ, Chen YC. Effect of music therapy on improving sleep quality in older adults: A systematic review and meta-analysis. J Am Geriatr Soc. 2021 Jul;69(7):1925-1932. doi: 10.1111/jgs.17149. Epub 2021 Apr 20. PubMed 33880759 ↗
  • J. Cohen, Statistical Power Analysis for the Behavioral Sciences., 2nd ed. 1988.
  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. PubMed 2748771 ↗
  • M. Ağargün, H. Kara, and Ö. Anlar, "Pitsburg Uyku Kalitesi İndeksinin Geçerliği ve Güvenirliği.," Türk Psikiyatr. Derg., vol. 7, no. 2, 1996.
  • Ö. C. Gürkan, "Menopoz semptomları değerlendirme ölçeğinin Türkçe formunun güvenirlik ve geçerliliği.," Hemşirelik Forumu Derg., vol. 3, pp. 30-35, 2005.
  • Hilditch JR, Lewis J, Peter A, van Maris B, Ross A, Franssen E, Guyatt GH, Norton PG, Dunn E. A menopause-specific quality of life questionnaire: development and psychometric properties. Maturitas. 1996 Jul;24(3):161-75. doi: 10.1016/s0378-5122(96)82006-8. Erratum In: Maturitas 1996 Nov;25(3):231. PubMed 8844630 ↗
  • N. H. ŞAHİN, N. H., Kharbouch, S. B., & Şahin, "Menopozal dönemlerdeki yaşam kalitesinin belirlenmesi.," Florence Nightingale Hemşirelik Dergisi, vol. 15, no. 59, pp. 82-90, 2007.
  • Meehan TC. Therapeutic touch as a nursing intervention. J Adv Nurs. 1998 Jul;28(1):117-25. doi: 10.1046/j.1365-2648.1998.00771.x. PubMed 9687138 ↗
  • J. Macrae, Therapeutic Touch. izmir: Ege Meta Yayınları, 2000.

Study documents

  • Study protocol · Sep 21, 2021
  • Statistical analysis plan · Sep 21, 2021
  • Informed consent form · Sep 21, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05180266
Lead sponsor
Inonu University
Responsible party
Fatma Keskin (Research Assistant, Inonu University) — Principal investigator
First posted
Jan 6, 2022
Start date
Sep 3, 2021
Primary completion
Aug 25, 2022 (estimated)
Completion
Aug 25, 2022 (estimated)
Last update
Jan 6, 2022

Study contacts

FATMA KESKİN, Msc
Contact
keskinfatma989@gmail.com
5448171444
FATMA KESKİN
principal investigator · Inonu University
YURDAGÜL YAĞMUR, Professor
study director · Inonu University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion