Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT07254520
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Reiki Therapy in Infants With Colic
Sponsor:
University of Yalova
Organization:
Study Overview
Official Title:
The Effect of Reiki Therapy on Colic Symptoms and Crying Duration in Infants With Infantile Colic, and on Maternal Fatigue and Quality of Life: A Double-Blind Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This double-blind, randomized controlled experimental study aims to determine the effect of Reiki therapy administered to infants with infantile colic (aged 3 weeks to 6 months) on infants' colic symptoms and crying duration, as well as on mothers' fatigue levels and quality of life.
The study population consists of infants aged 3 weeks to 6 months who are diagnosed with infantile colic and present to pediatric health and disease outpatient clinics between July 2025 and July 2026. A total of 44 infants meeting the inclusion criteria will be randomly assigned to either the Reiki group (n = 22) or the control group (n = 22).
Data will be collected using the Mother and Infant Descriptive Information Form, the Infantile Colic Scale, the Crying Duration Recording Form, the Visual Analogue Scale for Fatigue (for mothers), and the World Health Organization Quality of Life Scale (WHOQOL) (for mothers).
Reiki therapy will be administered to the intervention group twice on alternate days for 20-30 minutes per session. The control group will not receive any intervention.
The study population consists of infants aged 3 weeks to 6 months who are diagnosed with infantile colic and present to pediatric health and disease outpatient clinics between July 2025 and July 2026. A total of 44 infants meeting the inclusion criteria will be randomly assigned to either the Reiki group (n = 22) or the control group (n = 22).
Data will be collected using the Mother and Infant Descriptive Information Form, the Infantile Colic Scale, the Crying Duration Recording Form, the Visual Analogue Scale for Fatigue (for mothers), and the World Health Organization Quality of Life Scale (WHOQOL) (for mothers).
Reiki therapy will be administered to the intervention group twice on alternate days for 20-30 minutes per session. The control group will not receive any intervention.
Detailed Description:
The study population consisted of infants aged 3 weeks to 6 months who were diagnosed with infantile colic and met the inclusion criteria, presenting to pediatric health and disease outpatient clinics.
This study was designed as a double-blind, randomized controlled experimental study with a pretest-posttest design to determine the effect of Reiki therapy administered to infants with infantile colic on infants' colic symptoms and crying duration, as well as on mothers' fatigue levels and quality of life.
To ensure homogeneous distribution of the groups, randomization was performed using a computer-based program (http://www.randomization.com
, balanced permutation method). Infants who met the inclusion criteria and whose families agreed to participate were randomly assigned to either the experimental (Reiki) group or the control group according to the randomization list.
The control variables of the study were the infants' demographic characteristics, while the dependent variables were colic pain, crying duration, maternal fatigue level, and maternal quality of life scores.
This study was designed as a double-blind, randomized controlled experimental study with a pretest-posttest design to determine the effect of Reiki therapy administered to infants with infantile colic on infants' colic symptoms and crying duration, as well as on mothers' fatigue levels and quality of life.
To ensure homogeneous distribution of the groups, randomization was performed using a computer-based program (http://www.randomization.com
, balanced permutation method). Infants who met the inclusion criteria and whose families agreed to participate were randomly assigned to either the experimental (Reiki) group or the control group according to the randomization list.
The control variables of the study were the infants' demographic characteristics, while the dependent variables were colic pain, crying duration, maternal fatigue level, and maternal quality of life scores.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: