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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06299358
Other study ID # KMU_MPEPE_1
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 6, 2023
Est. completion date January 1, 2025

Study information

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

Clinical Trial Summary

Infantile colic is a developmental disorder that reduces comfort levels in infants with intense crying crises and has negative effects on the infant and family. The study is planned to measure the effect of the combination of maternal heart sound simulation, aromatic foot massage and maternal heart sound simulation and aromatic foot massage on the colic and comfort levels of infants with infantile colic. It is aimed to alleviate colic symptoms, increase comfort levels, regulate daily crying and sleep durations (increase in sleep durations, decrease in crying durations) and support the development of infants in this context by using maternal heart sound simulation, aromatic foot massage and their combined application.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Foot massage
Infants in the foot massage group will receive foot massage by the researcher on two consecutive days of the week for a total of four times. The massage will be performed in accordance with the specified application steps for 10 minutes just before the baby's restlessness starts.
Mother heart sound
The sound recorded by the researcher under appropriate conditions will be played to the babies in the maternal heart sound group from an appropriate distance. The sound will be played a total of four times, on two consecutive days of the week, just before the baby's restlessness begins and for half an hour.
Foot massage and maternal heart sound
Infants in the foot massage and maternal heart sound group will receive foot massage by the researcher on two consecutive days of the week for a total of four times. The massage will be performed in accordance with the specified application steps for 10 minutes just before the baby's restlessness starts. From the beginning of the massage, the pre-recorded maternal heart sound will be played to the infant for 30 minutes from an appropriate distance.

Locations

Country Name City State
Turkey Karamanoglu Mehmetbey University Karaman Center

Sponsors (1)

Lead Sponsor Collaborator
Karamanoglu Mehmetbey University

Country where clinical trial is conducted

Turkey, 

References & Publications (43)

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Outcome

Type Measure Description Time frame Safety issue
Primary Changes in colic scale ratings induced by maternal heart sound The colic scale consists of 19 questions. The minimum score that can be obtained from the scale in total is 19 and the maximum score is 114. A score of 48 and above on the scale indicates the presence of colic.After 48 points, each point increase indicates an increase in the severity of colic Two weeks
Primary Changes in comfort scale ratings as a result of maternal heart sound The comfort scale consists of 6 sub-dimensions.Each sub-dimension is evaluated between 1 and 5 points. Comfort is considered good if the total score is 15 or above, and inadequate if it is below. Two weeks
Primary Changes in colic scale assessments induced by foot massage The colic scale consists of 19 questions. The minimum score that can be obtained from the scale in total is 19 and the maximum score is 114. A score of 48 and above on the scale indicates the presence of colic.After 48 points, each point increase indicates an increase in the severity of colic Two weeks
Primary Changes in comfort scale assessments induced by foot massage The comfort scale consists of 6 sub-dimensions.Each sub-dimension is evaluated between 1 and 5 points. Comfort is considered good if the total score is 15 or above, and inadequate if it is below. Two weeks
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