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The Effects of Reiki Therapy in Infants With Colic

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
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07254520
Enrollment
44
Registered
2025-11-28
Start date
2024-07-01
Completion date
2025-07-01
Last updated
2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colic, Infantile, Reiki

Keywords

Reiki Therapy, Infantile colic, Maternal fatigue, Infant crying, Quality of life

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.

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.

Interventions

OTHERReiki

Infants in the Reiki group will receive Reiki therapy twice on alternate days, with each session lasting 20-30 minutes, administered by a certified Reiki practitioner following a standardized protocol.

Sponsors

University of Yalova
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Masking description

The research consists of 2 groups. These groups are Reiki group, control group.

Intervention model description

The study are conducted based on randomized controlled experimental design with double-blind, pre-test-post-test to determine. The research consists of 2 groups. These groups are Reiki group, control group.

Eligibility

Sex/Gender
ALL
Age
3 Weeks to 6 Months
Healthy volunteers
No

Inclusion criteria

* Infants aged between 3 weeks and 6 months. * Diagnosed with infantile colic by a physician during the study period. * Birth weight between 2500 and 4000 grams. * No presence of any chronic disease in the infant. * Family voluntarily agrees to participate in the study. * Mother has no visual or hearing impairments. * Mother is open to communication and cooperation. * Mother is able to read and understand Turkish. * Neither the mother nor the infant has received any form of energy therapy (e.g., yoga, Reiki, massage, meditation, or healing touch) within the last five months.

Exclusion criteria

* Infants with any acute or chronic illness. * Infants with congenital anomalies. * Mothers with diagnosed psychological or mental health disorders. * Infants diagnosed with lactose intolerance by a physician. * Infants who have previously been diagnosed with infantile colic and are continuing medical treatment for this condition.

Design outcomes

Primary

MeasureTime frameDescription
Change in Infantile Colic Symptom ScoreAt baseline and 7th dayMeasured using the Infantile Colic Scale completed by the mother.
Crying Duration of Infants with Infantile ColicRecorded by the mother over a 7-day period (24 hours per day).The mother records the start and end time of each crying episode over a 24-hour period for seven consecutive days to determine the total daily crying duration.
Change in Maternal Fatigue LevelAt baseline and 7th dayMaternal fatigue is assessed using the Visual Analogue Scale for Fatigue (VAS-F), completed by both the mother and an independent nurse. Measurements are taken to evaluate changes in maternal fatigue level.
Change in Maternal Quality of LifeAt baseline and 7th dayMaternal quality of life is assessed using the World Health Organization Quality of Life Assessment (WHOQOL), completed by both the mother and an independent nurse. Measurements are taken to evaluate changes in maternal quality of life

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORDuygu Demir, PhD

University of Yalova

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026