Caesarean SectionNCT06687447
The Effect of Two Methods Applied to Mothers on Insufficient Milk Perception, Breastfeeding Motivation, Fatigue, Anxiety
A study testing Oxycotin Massage Group and Reflexology Group in people with Caesarean Section, run by Ordu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Caesarean Section
- What is being tested?
- Oxycotin Massage Group and Reflexology Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Dec 2023to 6 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Büşra Nur GELDİ
Giresun, 28100
Büşra Nur GELDİ, +9005344313248, busranurgeldi@gmail.com
NÜLÜFER ERBİL, +90535 830 63 57, nerbil@odu.edu.tr
About this study
Official title: The Effect of Oxytocin Massage and Reflexology Applied to Primiparous Mothers After Cesarean Section on Insufficient Milk Perception, Breastfeeding Motivation, Fatigue, Anxiety and Uterus Involution
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.
- Conditions
- Caesarean Section
- Being tested
- Oxycotin Massage Group, Reflexology Group, Control Group
- Keywords
- reflexology, oxytocin massage, fatigue, anxiety, milk production
- Medical subject headings
- Fatigue, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycotin Massage GroupOther
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.
Reflexology GroupOther
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.
Control GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Oxycotin Massage Group | Active comparator | The researcher will perform oxytocin massage to the fifth-sixth rib along the patient's spine. Receives: Other: Oxycotin Massage Group |
| Reflexology Group | Active comparator | The researcher will apply pressure in different ways to the reflex points on the patient's sole with her fingers. Receives: Other: Reflexology Group |
| Control Group | Other | Patients in the control group will not undergo any intervention and will receive their routine care. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 hours
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.
Measured: 36 hours
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.
Measured: 36 hours
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.
Measured: 36 hours
Secondary outcomes (2)
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.
Measured: 36 hours
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.
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start6 Dec 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion6 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It was planned for three groups: oxytocin massage group, reflexology group and control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Nur GELDİ, Ordu University
- Investigators
- Büşra Nur GELDİ, Principal investigator, Ordu UniversityNülüfer ERBİL, Study director, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687447
- Sponsor's protocol ID
- ODU-HSI-BNG-01
- Status last verified
- Nov 2024
- First submitted
- 28 Dec 2023
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oxytocin Massage and Reflexology Applied to Primiparous Mothers After Cesarean Section on Insufficient Milk Perception, Breastfeeding Motivation, Fatigue, Anxiety and Uterus Involution
- ClinicalTrials.gov ID
- NCT06687447
- Acronym / sponsor ID
- ODU-HSI-BNG-01
- Conditions
- Caesarean Section
- Keywords
- reflexology, oxytocin massage, fatigue, anxiety, milk production
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 6 Jul 2025 (estimated)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- It was planned for three groups: oxytocin massage group, reflexology group and control group.
| Arm | Type | Receives |
|---|---|---|
| Oxycotin Massage Group | Active comparator | Other: Oxycotin Massage GroupThe researcher will perform oxytocin massage to the fifth-sixth rib along the patient's spine. |
| Reflexology Group | Active comparator | Other: Reflexology GroupThe researcher will apply pressure in different ways to the reflex points on the patient's sole with her fingers. |
| Control Group | Other | Other: Control GroupPatients in the control group will not undergo any intervention and will receive their routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxycotin Massage GroupPrimiparous 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. | Other | Oxycotin Massage Group |
| Reflexology GroupPrimiparous 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. | Other | Reflexology Group |
| Control GroupPrimiparous 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. | Other | Control Group |
Primary outcome
Insufficient Milk Perception Scale
Time frame: 36 hours
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.
Primipar Breastfeeding Motivation Scale
Time frame: 36 hours
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.
Visual Similarity Scale for Fatigue (VAS-F)
Time frame: 36 hours
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.
The State-Trait Anxiety Inventory (STAI)
Time frame: 36 hours
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.
2 secondary outcomes
Uterine Involution Evaluation Form
Time frame: 36 hours
Physiological Parameters Evaluation Form
Time frame: 36 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Büşra Nur GELDİ principal investigator
Ordu University
Nülüfer ERBİL study director
Ordu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxycotin Massage Group and Reflexology Group in people with Caesarean Section, run by Ordu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Büşra Nur GELDİ (+905344313248, busranurgeldi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insufficient Milk Perception Scale (time frame: 36 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.