NCT05344846

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 2, 2022

Status Verified

April 1, 2022

Enrollment Period

7 months

First QC Date

April 19, 2022

Last Update Submit

April 26, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in how to feed baby

    Nutrient content that she feeds her baby (Breastmilk, formula etc)

    Baseline, 7th day, 14th day

  • 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

  • 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 Outcomes (1)

  • Change in Perception of Insufficient Milk Questionnaire

    Baseline, 7th day, 14th day

Study Arms (2)

Guided imagery Group

EXPERIMENTAL

Guided imagery after cesarean

Other: Guided imagery

Standard care

NO INTERVENTION

The participants in the control group will perform routine care of the clinic.

Interventions

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.

Guided imagery Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Feeding

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

April 19, 2022

First Posted

April 25, 2022

Study Start

May 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

May 2, 2022

Record last verified: 2022-04