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Completed

NCT Number: NCT07254520

The Effects of Reiki Therapy in Infants With Colic

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.

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Key information

Conditions

Reiki Colic Colic, Infantile Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases

Age range

3 week–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Yalova

Yalova, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

reiki

Other

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.

Primary outcomes

  1. Change in Infantile Colic Symptom Score

    Time frame: At baseline and 7th day

    Measured using the Infantile Colic Scale completed by the mother.

  2. Crying Duration of Infants with Infantile Colic

    Time frame: Recorded 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.

  3. Change in Maternal Fatigue Level

    Time frame: At baseline and 7th day

    Maternal 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.

  4. Change in Maternal Quality of Life

    Time frame: At baseline and 7th day

    Maternal 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

Sponsors and collaborators

Lead sponsor

University of Yalova

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 28, 2025
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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