BreastfeedingNCT05344846
The Effect of Guided Imagery on Bonding and Breastfeeding After Cesarean
A study testing Guided imagery in people with Breastfeeding, run by Menekşe Nazlı AKER.
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. 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
- Breastfeeding
- What is being tested?
- Guided imagery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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.
- Conditions
- Breastfeeding
- Being tested
- Guided imagery
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided imageryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Guided imagery Group | Experimental | Guided imagery after cesarean Receives: Other: Guided imagery |
| Standard care | No intervention | The participants in the control group will perform routine care of the clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in how to feed baby
Nutrient content that she feeds her baby (Breastmilk, formula etc)
Measured: 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).
Measured: 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.
Measured: Baseline, 7th day, 14th day
Secondary outcomes (1)
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.
Measured: Baseline, 7th day, 14th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study startMay 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menekşe Nazlı AKER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Menekşe Nazlı AKER, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344846
- Sponsor's protocol ID
- 0555
- Status last verified
- Apr 2022
- First submitted
- 19 Apr 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Guided Imagery on Bonding and Breastfeeding After Cesarean; A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05344846
- Acronym / sponsor ID
- 0555
- Conditions
- Breastfeeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Menekşe Nazlı AKERUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 25 Apr 2022 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided imagery Group | Experimental | Other: Guided imageryGuided imagery after cesarean |
| Standard care | No intervention | –The participants in the control group will perform routine care of the clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Nullipar
- Single birth
- Baby being with mother
- Gestational age 37-42 weeks
- Birth weight between 2500-4000 g
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Guided imageryThe 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. | Other | Guided imagery Group |
Primary outcome
Change in how to feed baby
Time frame: Baseline, 7th day, 14th day
Nutrient content that she feeds her baby (Breastmilk, formula etc)
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).
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.
1 secondary outcome
Change in Perception of Insufficient Milk Questionnaire
Time frame: Baseline, 7th day, 14th day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Guided imagery in people with Breastfeeding, run by Menekşe Nazlı AKER.
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 8 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeynep Kaya (05529209750, zeynepbozkurt@tarsus.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in how to feed baby (time frame: Baseline, 7th day, 14th day). The study lists 3 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 2 May 2022.