ClinicalTrials.gg
RecruitingNCT06499311Updated Jul 12, 2024

Reflexology Versus Acupressure on Sleep Disturbance and Hot Flashes

An interventional study of Foot Reflexology and Acupressure in Postmenopausal Flushing and Hot Flashes, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to female participants aged 45 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-07-12.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
45 Years to 55 Years
Sex
Female
01

Study summary

World health Organization (WHO) estimates that by 2030, 1.2 billion women will be over 50 years old. With a prevalence of 70%, a hot flash is the most distressing symptoms associated with menopause. Postmenopausal associated sleep disturbances could affect those women social activities and one's daily positive functioning. Therefore, some patients and their providers seek alternative treatments such as relaxation techniques, acupressure, yoga, reflexology, regular exercise, balanced nutrition, herbal supplements, appropriate clothing, and frequent showers, have been shown to be effective in reducing symptoms associated with depression. So, this study will be the first one in this issue. Therefore, it will have valuable benefits in physical therapy field and scientific research.

Read the detailed description

Fifty-four postmenopausal women suffering from moderate to severe hot flashes diagnosed with hot flashes questionnaire, and sleep disturbances diagnosed with Pittsburgh quality sleep index >5. Their age ranged from 45-55 years old with their body mass index ranged from 25 to 30 kilogram per meter square. Outcome measures were Pittsburgh sleep quality index and Hot flashes questionnaire, both were conducted at baseline and after the end of the study program. after recruiting study population, they will be divided into two equal groups randomly. Group A; will received foot reflexology (medical border just above the heel, reflex points associated with adrenal, hypothalamus, pituitary glands, heart and lung via manual pressure at reflexology zone), for 15 minutes, 3 sessions per week for 6 weeks. Group B; will received acupressure ((Shenmen point, Sanyinjiao point, Fengchi point; Yintang point), for 21 minutes, 3 sessions per week for 6 weeks.

02

Conditions studied

  • Postmenopausal Flushing
  • Hot Flashes

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03

In context

Hot Flashes

339 studies on the registry are indexed under Hot Flashes; 56 are open to participants now.

This study's planned enrollment of 54 is below the median of 90 across 306 interventional studies indexed under Hot Flashes.

Browse Hot Flashes studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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

04

Who can participate

Ages eligible
45 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ranged from 45 to 55 years old.
  • Their ranged from 25 to 3 kilograms per meter square.
  • women suffering from moderate to sever hot flashes assessed by Hot Flashes Questionnaire.
  • Postmenopausal women suffering from sleep disturbances more than five assessed by Pittsburgh sleep quality index.

Exclusion criteria

Exclusion Criteria:

  • Any emotional stress during at least 6 months.
  • Any pharmacological medicines lead to sleep disturbances.
  • Any mental disorders affect their sleep cycle.
  • Taking hormone replacement therapy for the past six months.
  • Using herbal medicine to improve menopausal symptoms severity.
  • Circular job in particular night shifts.
  • Sensorineural problems in their feet.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
54 participants (estimated)

Study arms

  • Experimental
    Group A; Foot Reflexology

    Foot reflexology for 15 minutes, 3 sessions per week for 6 weeks will applied at the medical border just above the heel, also at associated reflex points associated with the adrenal, hypothalamus, pituitary glands, heart and lung via manual pressure at reflexology zone.

    Other: Foot Reflexology

  • Experimental
    Group B; Acupressure

    Acupressure for 21 minutes, 3 sessions per week for 6 weeks will applied at four acupoints points (Shenmen point at wrist crease, Sanyinjiao point; at both feet, and Fengchi point; at hairline within occipital region on dorsal neck surface), bilaterally in addition to one in midline at the top of nose on centerline between eyebrows ends (Yintang point).

    Other: Acupressure

Interventions

  • OtherFoot Reflexology

    Foot Reflexology is an alternative medical practice involving the application of pressure to specific points on the feet. It has been reported as a non-invasive complementary therapy that was addressed as an effective technique that is reported to reduce premenstrual symptoms.

  • OtherAcupressure

    Acupressure is a sort of massage therapy, was addressed as an effective technique that is reported to reduce premenstrual symptoms. Acupressure is a well-known form of Traditional Chinese Medicine that is a component of alternative treatments.

06

What researchers measure

Primary outcomes

  1. Pittsburgh Sleep Quality Index

    A reliable, validated, self-reported questionnaire for assessing sleep quality. It is available of validated Arabic form that consists of seven components, namely, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over a 1-month time interval. It held a good internal consistency, and convergent, also divergent validity. Each component scores are derived, each scored 'zero' means no difficulty, to 'three' means sever difficulty. component scores are summed to gain the whole score range 'zero to twenty-one' Higher scores indicates worse sleep quality.

    Time frame: Pretreatment and immediately Posttreatment.

Secondary outcomes

  1. Hot Flashes Questionnaire

    A valid and reliable measure for severity of hot flashes. It is an appropriately sensitive tool to negative changes over time, with its cut-points and minimally important differences could prove a useful tool in targeting important issues regarding therapeutic interventions, and monitoring management progress and response using a 0 (do not interfere) to 10 (completely interfere) point scale. A total score is computed by summing items. Higher scores indicate higher interference due to hot flashes and thus, greater impact on quality of life.

    Time frame: Pretreatment and immediately Posttreatment.

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06499311
Lead sponsor
Cairo University
Responsible party
Yasmeen Samir Abdelazeem Ali (Physical Therapist Specialist, Cairo University) — Principal investigator
First posted
Jul 12, 2024
Start date
Jul 1, 2024
Primary completion
Aug 1, 2024 (estimated)
Completion
Aug 20, 2024 (estimated)
Last update
Jul 12, 2024

Study contacts

Dr Mohamed A Awad, PHD
Contact
awad18111972@yahoo.com
00201224955140
Elham S Hassan, PHD
Contact
elhamramadan70@cu.edu.eg
00201206146539
Walid M Zidan, PHD
study chair · Head and Professor of Obstetrics and Gynecology Department

Oversight

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

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