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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06269458
Other study ID # ABU-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date December 26, 2023

Study information

Verified date February 2024
Source Antalya Bilim University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Purpose: This study was conducted to examine the effects of mother-baby yoga and massage on mother-baby bonding and the baby's sleep. Method: A randomised, crossover pilot study was conducted in the postpartum service of a hospital between January and November 2023, with 60 mothers and their babies in the postpartum period, 30 in each group. To the mothers and their babies included in the research, baby massage was applied to one group and mother-baby yoga was applied to the other. After four weeks, the groups' practices were changed. In the results of the research, characteristics related to attachment and sleep were evaluated.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 26, 2023
Est. primary completion date November 25, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 0 Days to 5 Days
Eligibility Inclusion Criteria: - Babies in the first week of postpartum - Healthy babies, - Therm (37-40 W), - The baby should be at normal birth weight (2500-4000gr), - Mothers who know how to read and writ Exclusion Criteria: - Mothers with communication problems, - Individuals whose mother or baby are monitored in intensive care after birth - If the mother has a physical disability or any chronic disease (hypertension, diabetes mellitus, etc.), - Psychological illness in the mother (major depression, psychosis, etc.), - Pregnancy through assisted reproductive techniques, - Mothers who are diagnosed with a sleep disorder and who have their babies treated for this reason.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Baby Massage
In the baby massage application, mothers were trained on baby massage and the massage applied by the mother to her baby was observed once. The baby massage video prepared by the researchers was shared with mothers. Mothers were informed about the importan
Monther-Baby Yoga
Mothers were asked to choose the most suitable time of day for themselves and the baby, to ensure that the baby was fed at least 45 minutes before yoga, and to practice yoga in a calm and dimly lit environment, listening to music or white noise of their choice. One yoga session lasted approximately 20 minutes. Mothers and their babies did mother-baby yoga three times a week for four weeks. Mothers were informed about the importance of having the same treatment room for each treatment. All mothers were called once a week by a researcher to provide counseling and follow-up of the process. At the end of four weeks, measurement tools were applied to all mothers and the groups were changed, massage was applied to the yoga group, and yoga intervention was applied to the massage group, as in the beginning of the research. At the end of four weeks, all mothers were evaluated for mother-infant attachment and the infant's sleep diary.

Locations

Country Name City State
Turkey Antalya Bilim Üniversitesi Antalya

Sponsors (1)

Lead Sponsor Collaborator
Antalya Bilim University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Attachment The Mother-Infant Attachment Scale developed by Taylor et al. was used to measure mother-infant attachment. The Turkish validity and reliability study of the scale was conducted by (Karakulak et al., 2016). The MIBS is designed to be administered from the first day after birth and allows the mother to express her feelings towards her baby with a single word. This scale, which can be easily and quickly administered by the mother or father alone, shows the relationship between the established bond and the mother's early mood. It was applied before and after the intervention (4 weeks).
Primary Weight and Sleep Sleep characteristics of the infants were assessed using a sleep diary form created by the researchers. The form included questions about the time of starting the bedtime routine, the time of going to bed, the number of nighttime awakenings, the duration of staying awake at night, the longest sleep time spent without waking up at night, the total sleep time at night, the number of daytime naps, and the total sleep time during the day (Agapinar et al., 2023; Del-Ponte et al., 2020; Hanifarizani et al., 2020; Mrljak et al., 2022). The mothers were asked to write in this diary to be recorded for one day during the first and last week of the implementation process. It was applied before and after the intervention (4 weeks).
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