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

NCT ID: NCT06687447

Last Updated: 2024-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-06

Study Completion Date

2025-07-06

Brief Summary

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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.

Detailed Description

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Conditions

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Caesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It was planned for three groups: oxytocin massage group, reflexology group and control group.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Random distribution of women included in the study to intervention groups and control groups was carried out at www.random.org. Which groups were intervention or control groups were determined by drawing lots at the beginning of the study. The numbers in the intervention groups and the control group will be placed in opaque envelopes, and the group in which the women who meet the criteria will be will be decided by drawing lots of sealed envelopes after the pre-test data is completed.The statistical analysis phase is blind since an independent statistician other than the researcher will perform the statistical analysis of the study.

Study Groups

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Oxycotin Massage Group

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

Group Type ACTIVE_COMPARATOR

Oxycotin Massage Group

Intervention Type OTHER

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 Group

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

Group Type ACTIVE_COMPARATOR

Reflexology Group

Intervention Type OTHER

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 Group

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

Group Type OTHER

Control Group

Intervention Type OTHER

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.

Interventions

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Oxycotin 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.

Intervention Type OTHER

Reflexology 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.

Intervention Type OTHER

Control 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.

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ordu University

OTHER

Sponsor Role lead

Responsible Party

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Büşra Nur GELDİ

Nurse, PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Büşra Nur GELDİ

Role: PRINCIPAL_INVESTIGATOR

Ordu University

Nülüfer ERBİL

Role: STUDY_DIRECTOR

Ordu University

Locations

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Büşra Nur GELDİ

Giresun, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Büşra Nur GELDİ

Role: CONTACT

+905344313248

Nülüfer ERBİL

Role: CONTACT

+905358306357

Facility Contacts

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Büşra Nur GELDİ

Role: primary

+9005344313248

NÜLÜFER ERBİL

Role: backup

+90535 830 63 57

Other Identifiers

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ODU-HSI-BNG-01

Identifier Type: -

Identifier Source: org_study_id

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