Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
Study NCT ID:
NCT06781866
Status:
COMPLETED
Last Update Posted:
2025-01-22
First Post:
2025-01-13
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Relaxation Massage Before Bedtime on Sleep Quality and Quantity.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008405', 'term': 'Massage'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-17', 'studyFirstSubmitDate': '2025-01-13', 'studyFirstSubmitQcDate': '2025-01-13', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep Efficiency', 'timeFrame': '9 hours', 'description': 'Total sleep time over Time spend in bed'}], 'secondaryOutcomes': [{'measure': 'Sustained Sleep Efficiency', 'timeFrame': '9 hours', 'description': 'Total sleep time/(Time in bed - Sleep latency stage)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Relaxation Massage', 'Manual Massage Therapy', 'Insomnia'], 'conditions': ['Massage']}, 'referencesModule': {'references': [{'pmid': '19122760', 'type': 'BACKGROUND', 'citation': 'Mai E, Buysse DJ. Insomnia: Prevalence, Impact, Pathogenesis, Differential Diagnosis, and Evaluation. Sleep Med Clin. 2008;3(2):167-174. doi: 10.1016/j.jsmc.2008.02.001. No abstract available.'}, {'pmid': '23972865', 'type': 'BACKGROUND', 'citation': 'Buyukyilmaz F, Asti T. The effect of relaxation techniques and back massage on pain and anxiety in Turkish total hip or knee arthroplasty patients. Pain Manag Nurs. 2013 Sep;14(3):143-54. doi: 10.1016/j.pmn.2010.11.001. Epub 2011 Jan 28.'}, {'pmid': '39857207', 'type': 'DERIVED', 'citation': 'Ntoumas I, Karatzaferi C, Giannaki CD, Papanikolaou F, Pappas A, Dardiotis E, Sakkas GK. The Impact of Relaxation Massage Prior to Bedtime on Sleep Quality and Quantity in People with Symptoms of Chronic Insomnia: A Home-Based Sleep Study. Healthcare (Basel). 2025 Jan 17;13(2):180. doi: 10.3390/healthcare13020180.'}]}, 'descriptionModule': {'briefSummary': 'Manual massage is an effective treatment approach for reducing general stress and promoting an overall sense of wellbeing. Relaxation massage aims to alleviate psychophysiological tension, enhance both blood and lymphatic circulation, and promote mental and physical relaxation. It is particularly beneficial for those with anxiety-related symptoms (such as generalized anxiety dis-order, social anxiety) and sleep disorders, aiming to improve calmness and promote sleepiness. The purpose of the present study is to assess the effectiveness of a single session of relaxation massage prior to bed-time on sleep quality and quantity indices, in individuals with symptoms of chronic insomnia.', 'detailedDescription': 'Study Design:\n\nThe current study will assess the impact of an in-house full-body deep relaxation massage session performed by a professional masseur in objective measurements of sleep quality and quantity in participants suffering from chronic insomnia just before they go to bed.\n\nThe volunteers of the current study will participate in 3 different scenarios, each 5 days apart: Scenario 1 is the control session when participants\' sleep will be recorded without any massage intervention. Participants will follow their usual bed-time routine.\n\nScenario 2, participants will receive a deep relaxation massage session lasting 40 min and follow the sleep recording set up before they follow their usual bedtime routine.\n\nScenario 3, participants will receive a placebo massage session lasting 40 min (oil rubbing application in participants\' body places similar to the massage session) and followed by the sleep recording set up before they follow their usual bedtime routine.\n\nScenarios 2 and 3 take place in random order for every participant.\n\nMethodology The individuals who are suffering from chronic insomnia and scored more than 15 in the Athens Insomnia Scale, will be the target group. All participants will sign an informed consent form in order to participate in the study. The study is approved by the University\'s Internal Ethics Committee.\n\nDemographic Characteristics: Demographic characteristics include age, gender, race/ethnicity.\n\nQuestionnaires Quality of sleep: The Athens Insomnia Scale, Weekly sleep diary and Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality and sleep abnormalities.\n\nRelaxation symptoms: The Relaxation State Questionnaire (RSQ) will be used for the assessment of relaxation symptoms.\n\nQuality of life: The SF36QoL questionnaire (SF-36) will be used for the assessment of the levels of quality of life.\n\nDepressive symptoms: The Beck Depression Inventory (BDI) questionnaire will be used for the assessment of depressive symptoms and signs.\n\nStress: The STATE - TRAIT ANXIETY INVENTORY (STAI) will be used for the assessment of stress levels.\n\nSleep Quality Assessment: Quality and quantity of sleep will be assessed by an overnight Home Sleep Test (HST) (SOMNOmedics). Specifically, HST records your brain waves, head movement, body position and snore rhythm during the study.\n\nMassage Intervention Relaxation Massage This technique will be performed all over the body. Exclusively, on specific leg muscle groups such as the gastrocnemius, the femoral biceps and quadriceps and in upper body muscle groups such as the triceps, the rhomboid, the deltoid, the trapezius and head areas. We applied slow strokes and deep finger pressure to ease away pain from the deepest layers of their muscles and connective tissues. The total duration of the relaxation massage will be 35-40 minutes.\n\nProcedure Individuals who achieve a score above 15 (on a scale of 1-24 points) and meet all required conditions will participate in the study.\n\nAll procedures will be performed in three visits, one week apart (weekly), and take place at each subject\'s home:\n\nAt the first visit, the Home Sleep Test (HST) we will used to conduct an 8 hour overnight sleep recording.\n\nA daily sleep questionnaire will be handed to the participant to fill out for the next 5 consecutive days.\n\nAlso, Relaxation State Questionnaire (RSQ) will be handed to the participant to fill out before and after massage protocol.\n\nOn the second and third visit, the same process will be repeated.\n\nStatistical Analysis The statistical analysis will be performed using IBM SPSS Statistics version 29.0 (IBM Corporation, Armonk NY, USA). An independent samples t-Test will be used to assess significant differences in basic characteristics between male and female participants. A General Linear Model-Repeated Measures will be used to examine if there are significant differences in the sleep parameters and sleep diary data between the 3 sessions. To assess normality, the Shapiro-Wilk test will be used alongside graphical repre-sentations, including the Normal Q-Q plot, Detrended Normal Q-Q plot, and Box Plot. The significance level is set at 5%. Beyond significance testing (p-value), effect size is also going to be considered to evaluate the magnitude of the effect.\n\nPower Analysis Sample size calculations were conducted using G\\*Power 3.1.\\[36\\] The post-hoc "GLM: Repeated measures, within factors" method was used for the power analysis. Based on an expected medium effect size of 0.25 (Cohen\'s f), a significance level of α = 0.05, and a desired power (1-β) of 0.82 (82%), the resulting minimum required sample size was calculated to be 20 participants. The critical F-value was 3.16 with (Ndf) = 2 and (Ddf) = 54.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Sex assigned at birth', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* score of ≥16 on the Athens Insomnia Scale (AIS-8)\n\nExclusion Criteria:\n\n* history of mental illness, dermatological diseases, allergies to massage oil and any acute or chronic condition that would limit the ability of the patient to participate or consent in the study'}, 'identificationModule': {'nctId': 'NCT06781866', 'acronym': 'GoodnightTouch', 'briefTitle': 'The Impact of Relaxation Massage Before Bedtime on Sleep Quality and Quantity.', 'organization': {'class': 'OTHER', 'fullName': 'University of Thessaly'}, 'officialTitle': 'The Impact of Relaxation Massage Prior to Bed-time on Sleep Quality and Quantity in People with Symptoms of Chronic In-somnia: a Home-Based Sleep Study.', 'orgStudyIdInfo': {'id': '2334-3/4-2/7.2.2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'For the control (CON) session participants will not receive any massage session and they will follow their usual bedtime routine.'}, {'type': 'EXPERIMENTAL', 'label': 'Relaxation Massage', 'description': 'For the relaxation massage (REL) session, participants will receive a massage session lasting for 45 minutes before bedtime and they will instructed to follow their usual bedtime routine', 'interventionNames': ['Other: Massage']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Massage', 'description': 'For the sham" massage (PLA) session, participants will receive a sham-massage session (full body oil rubbing) lasting for 45 minutes before bedtime and they will instructed to follow their usual bedtime routine', 'interventionNames': ['Other: Sham (No Treatment)']}], 'interventions': [{'name': 'Massage', 'type': 'OTHER', 'description': 'A relaxation type of massage will be used as the main massage intervention in this study. This technique is designed to promote deep relaxation, reduce stress, and enhance overall well-being. It is characterized by the use of five primary techniques performed on the full body, including the palms and feet. Specifically, these techniques consist of effleurage (long, gliding strokes), petrissage (kneading and squeezing), tapotement (rhythmic tapping), friction (deep, circular rubbing), and vibration or shaking movements (Table 1). In addition to these, the technique also incorporates rhythmic movements and deep light pressure to enhance relaxation and alleviate tension. It is designed to promote relaxation, increase blood circulation, relieve muscle tension, improve flexibility and promote relaxation and reduce pain. The total duration of the Relaxation massage is 45 minutes.', 'armGroupLabels': ['Relaxation Massage']}, {'name': 'Sham (No Treatment)', 'type': 'OTHER', 'description': "The Sham massage (PLA) will be used as a control session, without applying the deeper techniques that characterize the Relaxation massage in order to eliminate the influence of the human touch sensation on the participant's skin. This massage consisted only of superficial oil application movements over the entire body, without any added pressure or deep muscle manipulation. Oil was used to facilitate smooth gliding, mimicking the sensation of a full massage, but without the intensity or techniques aimed at muscle tissue relaxation. The total duration of the sham massage is 45 minutes.", 'armGroupLabels': ['Sham Massage']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'GR42100', 'city': 'Trikala', 'state': 'Thessaly', 'country': 'Greece', 'facility': 'School of Physical Education, Sports and Dietetics, TEFAA', 'geoPoint': {'lat': 39.55493, 'lon': 21.76837}}], 'overallOfficials': [{'name': 'Giorgos Sakkas, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Thessaly'}]}, 'ipdSharingStatementModule': {'url': 'https://www.dropbox.com/scl/fo/ja50mwmv8cjid7elrd0w3/AM_8gYnrK8QSnbMwFC042BI?rlkey=k96adt0zvv349z5kngbyu1vrw&dl=0', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '01/01/2025 - 01/01/2026', 'ipdSharing': 'YES', 'description': 'Full data set, IRB protocol, consent form', 'accessCriteria': 'Written request to the PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Thessaly', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Nicosia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Giorgos K. Sakkas', 'investigatorAffiliation': 'University of Thessaly'}}}}