ClinicalTrials.gg
RecruitingNCT06687447Updated Nov 13, 2024

The Effect of Two Methods Applied to Mothers on Insufficient Milk Perception, Breastfeeding Motivation, Fatigue, Anxiety

An interventional study of Oxycotin Massage Group and Reflexology Group in Caesarean Section, sponsored by T.C. ORDU ÜNİVERSİTESİ. Recruiting at 1 site in Turkey. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-13.

Sponsored by T.C. ORDU ÜNİVERSİTESİ · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Dec 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

Although the World Health Organization predicts the caesarean section rate to be 10-15%, the caesarean section rate in Turkey is 52%, more than three times the international standard. It is very important to eliminate the physical and psychosocial problems experienced by women during this period, to encourage breastfeeding, and at the same time to protect and improve maternal health. Maintaining the mother's well-being after cesarean section and supporting pharmacological treatment with non-pharmacological practices have an important place in nursing care. Therefore, this study will examine the effects of oxytocin massage and reflexology applied to mothers in the post-cesarean period on the perception of insufficient milk, breastfeeding motivation, fatigue, anxiety and uterine involution.

02

Conditions studied

  • Caesarean Section

Keywords

  • reflexology
  • oxytocin massage
  • fatigue
  • anxiety
  • milk production
03

In context

Fatigue

2,229 studies on the registry are indexed under Fatigue; 426 are open to participants now.

This study's planned enrollment of 90 is above the median of 54 across 1,757 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

T.C. ORDU ÜNİVERSİTESİ is the lead sponsor of 87 studies on the registry; 12 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

  • Mothers who gave birth at the age of 18 and over
  • The one who is married
  • At least primary school graduate,
  • Primiparous mothers who gave birth by cesarean section,
  • Having a single, healthy newborn at full term,
  • Those who did not experience any problems during pregnancy and the early postpartum period,
  • The tissue integrity in the area to be applied is complete and healthy,
  • Breastfeeding her baby after birth,
  • The baby is healthy, has no problems with the sucking reflex and does not have any congenital anomalies,
  • Women who agree to participate in the research will be included in the study.

Exclusion criteria

Exclusion Criteria:

  • Those who gave birth by cesarean section before the 37th week of pregnancy,
  • Women who gave birth by cesarean section with combined anesthesia,
  • Discharged before 36 hours after birth,
  • Having chronic diseases such as heart disease, diabetes, hypertension,
  • Those with infectious diseases, infections, open wounds, masses, fractures, dislocations, deformities, varicose veins, burns, eczema, hematomas, thrombophlebitis, deep vein thrombosis on the foot skin,
  • Experiencing any postpartum complications,
  • Their baby is not with their mother for any reason,
  • Those who have received a psychiatric diagnosis such as anxiety and depression,
  • Women who want to leave the research at any stage of the research
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    Oxycotin Massage Group

    The researcher will perform oxytocin massage to the fifth-sixth rib along the patient's spine.

    Other: Oxycotin Massage Group

  • Active comparator
    Reflexology Group

    The researcher will apply pressure in different ways to the reflex points on the patient's sole with her fingers.

    Other: Reflexology Group

  • Other
    Control Group

    Patients in the control group will not undergo any intervention and will receive their routine care.

    Other: Control Group

Interventions

  • OtherOxycotin Massage Group

    Primiparous women will be visited 12 hours after cesarean delivery, women will be informed, verbal and written consent will be obtained from women who want to participate in the study, and pre-test data will be collected by the researcher. The pre-test data of the research were it will be collected by face-to-face interview technique in approximately 25 minutes. The height of the fundus part of the uterus will be measured with a tape measure. The woman's physiological parameters will be measured by the researcher. At this stage, the patient will receive an oxytocin massage for 10 minutes while in a sitting position. One hour after the application (13th hour after cesarean section), the physiological parameters of the patients will be measured again by the researcher. 24 hours after the application (36 hours after cesarean section), the data of the patients will be collected again by the researcher and uterine involution and physiological parameters will be evaluated.

  • OtherReflexology Group

    Primiparous women will be visited 12 hours after cesarean delivery, women will be informed women who want to participate in the study, and pre-test data will be collected. The pre-test data of the research were it will be collectedapproximately 25 minutes. The height of the fundus part of the uterus will be measured with a tape measure. The woman's physiological parameters will be measured. In practice; The foot is first relaxed and warmed up with passive movements, then the sole of the foot is scanned with the thumb walking crawling technique. The application will be applied first to the right foot for 10 minutes and then to the left foot for a total of 20 minutes. One hour after the application (13th hour after cesarean section), the physiological parameters of the patients will be measured again. 24 hours after the application (36 hours after cesarean section), the data of the patients will be collected again and uterine involution and physiological parameters will be evaluated.

  • OtherControl Group

    Primiparous women will be visited 12 hours after cesarean delivery, women will be informed, verbal and written consent will be obtained from women who want to participate in the study, and pre-test data will be collected by the researcher. The pre-test data of the research were it will be collected by face-to-face interview technique in approximately 25 minutes. The height of the fundus part of the uterus will be measured with a tape measure. The woman's physiological parameters will be measured by the researcher. Patients in the control group will not undergo any intervention and will receive their routine care. One hour after the application (13th hour after cesarean section), the physiological parameters of the patients will be measured again by the researcher. 24 hours after the application (36 hours after cesarean section), the data of the patients will be collected again by the researcher and uterine involution and physiological parameters will be evaluated.

06

What researchers measure

Primary outcomes

  1. Insufficient Milk Perception Scale

    The Insufficient Milk Perception Scale consists of a total of 6 questions and a single subscale. The first question on the scale is whether the mother finds her milk sufficient. The first question is answered as yes or no. The other 5 questions are scored between 0-10. The given score indicates that as it approaches zero, the mother perceives her milk as inadequate, and as she approaches 10, she perceives enough. A minimum of zero points and a maximum of 50 points can be obtained from the scale. The high score indicates that milk is sufficiently perceived.

    Time frame: 36 hours

  2. Primipar Breastfeeding Motivation Scale

    The Insufficient Milk Perception Scale consists of a total of 6 questions and a single subscale. The first question on the scale is whether the mother finds her milk sufficient. The first question is answered as yes or no. The other 5 questions are scored between 0-10. The given score indicates that as it approaches zero, the mother perceives her milk as inadequate, and as she approaches 10, she perceives enough. A minimum of zero points and a maximum of 50 points can be obtained from the scale. The high score indicates that milk is sufficiently perceived.

    Time frame: 36 hours

  3. Visual Similarity Scale for Fatigue (VAS-F)

    The scale consists of 29 items and has a 7-point Likert type and 4 sub-dimensions. These sub-dimensions; the value given to breastfeeding (items 1,2,4,6,8,10,12,14,15,20,24,25,28), self-efficacy (items 9,16,17,18,19,26,29 ), midwife support (items 21,22,23,27), success expectation (items 3,5,7,11,13). As the score obtained from each sub-dimension increases, the breastfeeding motivation level of that sub-dimension increases.

    Time frame: 36 hours

  4. The State-Trait Anxiety Inventory (STAI)

    The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress. Form has 20 items for assessing for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.

    Time frame: 36 hours

Secondary outcomes

  1. Uterine Involution Evaluation Form

    This form is a form prepared by the researcher in line with the literature, in which the measurement of the length of the uterus is recorded and the uterine involution process of postpartum women is evaluated. The length of the uterus; It will be done by measuring the distance between the fundus of the uterus and the symphysis pubis with the help of a tape measure. When measuring uterine length, women will be ensured that their bladder is empty and the same tape measure will be used in all measurements.

    Time frame: 36 hours

  2. Physiological Parameters Evaluation Form

    In this study, heart rate, body temperature, oxygen saturation, respiratory rate and blood pressure values will be measured and recorded in the Physiological Parameters Form.

    Time frame: 36 hours

07

Study locations

1 of 1 sites recruiting
  • Büşra Nur GELDİ
    Giresun, 28100, Turkey
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2023 (actual). Primary completion is estimated for Dec 2024, 12 months after the start.

Of 936 non-industry interventional studies with no phase under Fatigue, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's planned 12 months is close to that.

Counting every sponsor, half of 989 studies reached it within 11 months; a quarter within 5 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 28, 2023
First posted
Nov 13, 2024
StartActual
Dec 6, 2023
Primary completionEst.
Dec 30, 2024
CompletionEst.
Jul 6, 2025
Last update
Nov 13, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06687447
Lead sponsor
T.C. ORDU ÜNİVERSİTESİ
Responsible party
Büşra Nur GELDİ (Nurse, PhD Student, T.C. ORDU ÜNİVERSİTESİ) — Principal investigator
First posted
Nov 13, 2024
Start date
Dec 6, 2023
Primary completion
Dec 30, 2024 (estimated)
Completion
Jul 6, 2025 (estimated)
Last update
Nov 13, 2024

Study contacts

Büşra Nur GELDİ
Contact
busranurgeldi@gmail.com
+905344313248
Nülüfer ERBİL
Contact
nulurerbil@gmail.com
+905358306357
Büşra Nur GELDİ
principal investigator · T.C. ORDU ÜNİVERSİTESİ
Nülüfer ERBİL
study director · T.C. ORDU ÜNİVERSİTESİ

Oversight

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

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