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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003085', 'term': 'Colic'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019124', 'term': 'Therapeutic Touch'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The research consists of 2 groups. These groups are Reiki group, control group.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-19', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Infantile Colic Symptom Score', 'timeFrame': 'At baseline and 7th day', 'description': 'Measured using the Infantile Colic Scale completed by the mother.'}, {'measure': 'Crying Duration of Infants with Infantile Colic', 'timeFrame': 'Recorded by the mother over a 7-day period (24 hours per day).', 'description': '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.'}, {'measure': 'Change in Maternal Fatigue Level', 'timeFrame': 'At baseline and 7th day', 'description': '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.'}, {'measure': 'Change in Maternal Quality of Life', 'timeFrame': 'At baseline and 7th day', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Reiki Therapy', 'Infantile colic', 'Maternal fatigue', 'Infant crying', 'Quality of life'], 'conditions': ['Reiki', 'Colic, Infantile']}, 'referencesModule': {'references': [{'pmid': '23203652', 'type': 'BACKGROUND', 'citation': 'Den Oudsten BL, Zijlstra WP, De Vries J. The minimal clinical important difference in the World Health Organization Quality of Life instrument--100. Support Care Cancer. 2013 May;21(5):1295-301. doi: 10.1007/s00520-012-1664-8. Epub 2012 Dec 1.'}, {'pmid': '12811319', 'type': 'BACKGROUND', 'citation': 'Cirgin Ellett ML, Murphy D, Stroud L, Shelton RA, Sullivan A, Ellett SG, Ellett LD. Development and psychometric testing of the infant colic scale. Gastroenterol Nurs. 2003 May-Jun;26(3):96-103. doi: 10.1097/00001610-200305000-00002.'}, {'pmid': '1307172', 'type': 'BACKGROUND', 'citation': 'Pavliuk-Pavliuchenko LL. [An osteotome for the nose]. Stomatologiia (Mosk). 1992 May-Dec;(3-6):84-5. No abstract available. Russian.'}, {'pmid': '27058159', 'type': 'RESULT', 'citation': 'Charkhandeh M, Talib MA, Hunt CJ. The clinical effectiveness of cognitive behavior therapy and an alternative medicine approach in reducing symptoms of depression in adolescents. Psychiatry Res. 2016 May 30;239:325-30. doi: 10.1016/j.psychres.2016.03.044. Epub 2016 Mar 30.'}, {'pmid': '21998438', 'type': 'RESULT', 'citation': 'Birocco N, Guillame C, Storto S, Ritorto G, Catino C, Gir N, Balestra L, Tealdi G, Orecchia C, Vito GD, Giaretto L, Donadio M, Bertetto O, Schena M, Ciuffreda L. The effects of Reiki therapy on pain and anxiety in patients attending a day oncology and infusion services unit. Am J Hosp Palliat Care. 2012 Jun;29(4):290-4. doi: 10.1177/1049909111420859. Epub 2011 Oct 13.'}, {'pmid': '6890412', 'type': 'RESULT', 'citation': 'Wein P, Handler M, Chadda KD. Severe thrombocytopenia as a result of contrast left ventricular angiography. Cathet Cardiovasc Diagn. 1982;8(5):495-9. doi: 10.1002/ccd.1810080511.'}, {'pmid': '32150292', 'type': 'RESULT', 'citation': 'Hjern A, Lindblom K, Reuter A, Silfverdal SA. A systematic review of prevention and treatment of infantile colic. Acta Paediatr. 2020 Sep;109(9):1733-1744. doi: 10.1111/apa.15247. Epub 2020 Jun 2.'}, {'pmid': '29676928', 'type': 'RESULT', 'citation': 'Icke S, Genc R. Effect of Reflexology on Infantile Colic. J Altern Complement Med. 2018 Jun;24(6):584-588. doi: 10.1089/acm.2017.0315. Epub 2018 Apr 20.'}, {'pmid': '4934450', 'type': 'RESULT', 'citation': 'Lecuire J, Dechaume JP, Buffard P, Bochu M. [Meningiomas of the posterior cranial fossa]. Neurochirurgie. 1971 May;17:1-146. No abstract available. French.'}, {'pmid': '26858170', 'type': 'RESULT', 'citation': 'Thrane SE, Maurer SH, Ren D, Danford CA, Cohen SM. Reiki Therapy for Symptom Management in Children Receiving Palliative Care: A Pilot Study. Am J Hosp Palliat Care. 2017 May;34(4):373-379. doi: 10.1177/1049909116630973. Epub 2016 Feb 7.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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).\n\nData 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).\n\nReiki 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.", 'detailedDescription': "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.\n\nThis 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.\n\nTo ensure homogeneous distribution of the groups, randomization was performed using a computer-based program (http://www.randomization.com\n\n, 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '3 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants aged between 3 weeks and 6 months.\n* Diagnosed with infantile colic by a physician during the study period.\n* Birth weight between 2500 and 4000 grams.\n* No presence of any chronic disease in the infant.\n* Family voluntarily agrees to participate in the study.\n* Mother has no visual or hearing impairments.\n* Mother is open to communication and cooperation.\n* Mother is able to read and understand Turkish.\n* 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.\n\nExclusion Criteria:\n\n* Infants with any acute or chronic illness.\n* Infants with congenital anomalies.\n* Mothers with diagnosed psychological or mental health disorders.\n* Infants diagnosed with lactose intolerance by a physician.\n* Infants who have previously been diagnosed with infantile colic and are continuing medical treatment for this condition.'}, 'identificationModule': {'nctId': 'NCT07254520', 'briefTitle': 'The Effects of Reiki Therapy in Infants With Colic', 'organization': {'class': 'OTHER', 'fullName': 'University of Yalova'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'duygudemir Colic'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reiki Group', 'description': '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.', 'interventionNames': ['Other: Reiki']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Infants in the control group will receive only routine pediatric care and will not receive any Reiki therapy or additional intervention.'}], 'interventions': [{'name': 'Reiki', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Reiki Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yalova', 'state': 'Yalova', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Duygu Demir, PhD', 'role': 'CONTACT', 'email': 'duygu.demir@yalova.edu.tr', 'phone': '+905053662358'}], 'facility': 'University of Yalova', 'geoPoint': {'lat': 40.65501, 'lon': 29.27693}}], 'centralContacts': [{'name': 'Duygu Demir, PhD', 'role': 'CONTACT', 'email': 'duygu.demir@yalova.edu.tr', 'phone': '05053662358'}], 'overallOfficials': [{'name': 'Duygu Demir, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Yalova'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Yalova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, RN', 'investigatorFullName': 'Duygu Demir', 'investigatorAffiliation': 'University of Yalova'}}}}