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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05344846
Other study ID # 0555
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2022
Est. completion date December 2022

Study information

Verified date April 2022
Source Ankara University
Contact Zeynep Kaya
Phone 05529209750
Email zeynepbozkurt@tarsus.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 64
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Guided imagery
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Menekse Nazli AKER

Outcome

Type Measure Description Time frame Safety issue
Primary Change in how to feed baby Nutrient content that she feeds her baby (Breastmilk, formula etc) Baseline, 7th day, 14th day
Primary Change in The Mother-to-Infant Bonding Scale 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
Primary Change in Breastfeeding Self-Efficacy Scale 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 Change in Perception of Insufficient Milk Questionnaire 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
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