- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05344846
The Effect of Guided Imagery on Bonding and Breastfeeding After Cesarean
The Effect of Guided Imagery on Bonding and Breastfeeding After Cesarean; A Randomized Controlled Study
The aim of this study is to evaluate the effect of guided imagery after cesarean section on mother-infant bonding and breastfeeding.
The study will be carried out in two different groups. The practice will start with meeting the women 6-10 hours after cesarean section. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.
Intervention Group; The individuals in this group will be provided with guided imagery application. Guided imagery will be applied to the participants in the hospital environment 6-10 hours after the cesarean section. Afterwards, guided imagery application will be requested every day for two weeks.
Control Group; The participants in the control group will perform routine care of the clinic.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zeynep Kaya
- Phone Number: 05529209750
- Email: zeynepbozkurt@tarsus.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Nullipar
- Single birth
- Baby being with mother
- Gestational age 37-42 weeks
- Birth weight between 2500-4000 g
- APGAR score of 7 or higher in the 1st and 5th minutes
- The mother does not have a health problem that prevents breastfeeding
- Absence of conditions that prevent sucking, such as frenulum or palate problems
Exclusion Criteria:
- Participant's non-compliance with the research plan
- Interruption of breastfeeding for reasons such as health problems of the mother or baby
- Participants receive professional support for breastfeeding during the study process
- Hearing loss and deafness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Guided imagery Group
Guided imagery after cesarean
|
The individuals in this group will be provided with guided imagery application.
Guided imagery will be applied to the participants in the hospital environment 6-10 hours after the cesarean section.
Afterwards, guided imagery application will be requested every day for two weeks.
|
No Intervention: Standard care
The participants in the control group will perform routine care of the clinic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in how to feed baby
Time Frame: Baseline, 7th day, 14th day
|
Nutrient content that she feeds her baby (Breastmilk, formula etc)
|
Baseline, 7th day, 14th day
|
Change in The Mother-to-Infant Bonding Scale
Time Frame: Baseline, 7th day, 14th day
|
The scale consists of eight adjectives (loving, resentful, neutral or felt nothing, joyful, dislike, protective, disappointed and aggressive), each followed by a four-point Likert scale ranging from "Very much" (0) to "Not at all" (5).
When the adjective reflects a negative emotional response, the scoring is reversed.
Thus, possible scores on the scale range between 0 and 24, with high scores indicating a problematic mother-to-infant bond (Taylor et al. 2005).
|
Baseline, 7th day, 14th day
|
Change in Breastfeeding Self-Efficacy Scale
Time Frame: Baseline, 7th day, 14th day
|
The 14-item scale was developed by Dennis (2003).
The scale is a 5-point Likert-type scale (1= 'I am not sure at all' and 5 = 'I am always sure').
The scale's minimum score is 14 and the maximum score is 70.
An elevated score shows an increase in breastfeeding self-efficacy.
|
Baseline, 7th day, 14th day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Perception of Insufficient Milk Questionnaire
Time Frame: Baseline, 7th day, 14th day
|
This scale, developed by McCarter-Spaulding for determining the perception of insufficient breast milk, is a six-question form.
The scale's minimum score is 0 and the maximum score is 50.
A high total score indicates that milk sufficiency perception is also high.
|
Baseline, 7th day, 14th day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0555
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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