Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT07148869
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-29
First Post:
2025-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Laughter Yoga Practice in Hypertension Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D027641', 'term': 'Laughter Therapy'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': '2 group'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2025-07-18', 'studyFirstSubmitQcDate': '2025-08-26', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Life Findings Record Form', 'timeFrame': 'Day 1', 'description': "The researcher will measure the patient's blood pressure, oxygen saturation, pulse and respiratory rate, body temperature 10 minutes before and 10 minutes after the laughter yoga session and record them on this form."}, {'measure': 'Sleep Quality', 'timeFrame': 'Day 1', 'description': "Pittsburgh Sleep Quality Index (PSQI): The Turkish validity and reliability of the scale developed by Buysse et al. to evaluate sleep quality in the last month was performed by Ağargün et al. The scale consists of 18 items and 7 components. The total PDQI score is the sum of the scores of these components and the total score takes a value between 0-21. A PDQI total score \\>5 indicates 'poor sleep quality' and a PDQI total score \\<5 indicates 'good sleep quality'. The Cronbach alpha reliability coefficient of the Turkish version of the scale was found to be 0.80."}, {'measure': 'State and Trait Anxiety Inventory', 'timeFrame': 'Day 1', 'description': 'State and Trait Anxiety Inventory (STAI): The scale developed by Spielberger et al. (1970) was adapted to Turkish culture and validity and reliability studies were conducted by Öner and Le Compte (1983). The scale consists of two separate forms, a 20-item State Anxiety Scale and a 20-item Trait Anxiety Scale. The total score value obtained from the scales is between 20 and 80 points. Scores close to 80 points indicate a high level of anxiety. Scale reliability according to Kuder-Richardson reliability: 0.83 to 0.87 for Trait Anxiety Scale and 0.94 to 0.96 for State Anxiety Scale. Item reliability correlations were found between 0.34 and 0.72 for the Trait Anxiety Scale and between 0.42 and 0.85 for the State Anxiety Scale. In the scale, which measures momentary (temporary) anxiety at a reliable level, participants tick the most appropriate option from the options of "not at all", "a little", "a lot" or "completely" for each statement in the state anxiety scores. Positive scores (incre'}, {'measure': 'Hill-Bone Hypertension Treatment Compliance', 'timeFrame': 'Day 1', 'description': 'Hill-Bone Hypertension Treatment Compliance Scale: The Turkish validity and reliability of the scale developed by Kim et al. was performed by Karademir et al. The four-point Likert-type scale (0=never, 1=sometimes, 2=most of the time and 3=always) consists of 14 items and has three sub-dimensions including interview, medical and nutrition. The scores that can be obtained from the scale vary between 0 (perfect agreement) and 42 (incompatible). As the score obtained from the scale increases, treatment compliance decreases. While the Cronbach alpha value of the original scale was found to be 0.84, the Cronbach alpha reliability coefficient of the Turkish version was found to be 0.83.'}, {'measure': 'Laughter Yoga Satisfaction', 'timeFrame': 'Day 4', 'description': 'Laughter Yoga Satisfaction Scale: In the first phase of the study, the scale developed by the researcher and the validity-reliability study will be used. On a scale ranging from a minimum of 13 to a maximum of 65, it is shown that satisfaction increases as the score increases.'}], 'secondaryOutcomes': [{'measure': 'Sleep Quality', 'timeFrame': 'four weeks later', 'description': "Pittsburgh Sleep Quality Index (PSQI): The Turkish validity and reliability of the scale developed by Buysse et al. to evaluate sleep quality in the last month was performed by Ağargün et al. The scale consists of 18 items and 7 components. The total PDQI score is the sum of the scores of these components and the total score takes a value between 0-21. A PDQI total score \\>5 indicates 'poor sleep quality' and a PDQI total score \\<5 indicates 'good sleep quality'. The Cronbach alpha reliability coefficient of the Turkish version of the scale was found to be 0.80."}, {'measure': 'State and Trait Anxiety Inventory', 'timeFrame': 'four weeks later', 'description': 'State and Trait Anxiety Inventory (STAI): The scale developed by Spielberger et al. (1970) was adapted to Turkish culture and validity and reliability studies were conducted by Öner and Le Compte (1983). The scale consists of two separate forms, a 20-item State Anxiety Scale and a 20-item Trait Anxiety Scale. The total score value obtained from the scales is between 20 and 80 points. Scores close to 80 points indicate a high level of anxiety. Scale reliability according to Kuder-Richardson reliability: 0.83 to 0.87 for Trait Anxiety Scale and 0.94 to 0.96 for State Anxiety Scale. Item reliability correlations were found between 0.34 and 0.72 for the Trait Anxiety Scale and between 0.42 and 0.85 for the State Anxiety Scale. In the scale, which measures momentary (temporary) anxiety at a reliable level, participants tick the most appropriate option from the options of "not at all", "a little", "a lot" or "completely" for each statement in the state anxiety scores. Positive scores (incre'}, {'measure': 'Hill-Bone Hypertension Treatment Compliance', 'timeFrame': 'four weeks later', 'description': 'Hill-Bone Hypertension Treatment Compliance Scale: The Turkish validity and reliability of the scale developed by Kim et al. was performed by Karademir et al. The four-point Likert-type scale (0=never, 1=sometimes, 2=most of the time and 3=always) consists of 14 items and has three sub-dimensions including interview, medical and nutrition. The scores that can be obtained from the scale vary between 0 (perfect agreement) and 42 (incompatible). As the score obtained from the scale increases, treatment compliance decreases. While the Cronbach alpha value of the original scale was found to be 0.84, the Cronbach alpha reliability coefficient of the Turkish version was found to be 0.83.'}, {'measure': 'Laughter Yoga Satisfaction', 'timeFrame': 'four weeks later', 'description': 'Laughter Yoga Satisfaction Scale: In the first stage of the research, the scale developed by the researcher and the validity-reliability study will be used.'}, {'measure': 'Life Findings Record Form', 'timeFrame': 'up to 4 weeks', 'description': "The researcher will measure the patient's blood pressure, oxygen saturation, pulse and respiratory rate, body temperature 10 minutes before and 10 minutes after the laughter yoga session and record them on this form."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Sleep Quality', 'laughter yoga', 'anxiety', 'treatment compliance'], 'conditions': ['Hypertension', 'Laughter Yoga']}, 'descriptionModule': {'briefSummary': 'Hypertension (HT), which is defined as an arterial blood pressure higher than 140/90 mmHg, is an important health problem because it causes serious complications and is commonly seen in the community.\n\nLaughter as an expression of humour has been accepted as a good medicine for centuries. It is also one of the practices used in nursing care according to the Nursing Interventions Classification (NIC). Laughter yoga developed by Dr. Madan Kataria, an Indian medical doctor, in 1995 includes deep breathing exercises, meditation, childish games and laughter without humour. In practice, individual sessions as well as group sessions can be held. It is important to form groups of at least 5 people in terms of the dynamics of the group. The first stage in laughter yoga is warm-up exercises. Hands are clapped parallel to each other, acupuncture points are stimulated by stimulating the fingertips and palms as clapping is performed, and a vocal rhythm in the form of ho, ho, ha-ha-ha is added to the last clapping movement. In the second stage, breathing exercises, the participants raise their arms to the sky as if praying, inhale and hold their breath for 4-5 seconds after deep inspiration and exhale rhythmically and slowly. The third stage includes childish games. The last stage is the stage of laughter exercises in which unreasonable laughter is thrown by imagining situations as if they did not exist. These exercises include milkshake laughter exercises, lion laughter, hot soup laughter, hugging laughter, bird laughter, etc. It is recommended that each session should be at least 20 minutes and should be applied for at least 8 weeks. At the end of the session, individuals are provided to relax by meditation.\n\nThe aim of this thesis study;\n\n* Developing the Laughter Yoga Satisfaction Scale and\n* To investigate the effect of laughter yoga practice on anxiety, sleep quality, treatment compliance and satisfaction in hypertension patients.\n\nHypotheses of the study H1-1: Laughter Yoga Satisfaction Scale is a valid scale. H2-1: Laughter Yoga Satisfaction Scale is a reliable scale. H3-1: Laughter yoga reduces the anxiety level of hypertension patients. H4-1: Laughter yoga improves the sleep quality of hypertension patients. H5-1: Laughter yoga increases the level of compliance with treatment in hypertension patients.\n\nH6-1: Hypertension patients have a high level of satisfaction with laughter yoga.\n\nH7-1: Laughter yoga has positive effects on vital signs of hypertension patients.', 'detailedDescription': 'Patient Information Form: In the form developed by the researcher as a result of literature review, some sociodemographic characteristics of the patients (age, gender, educational status, marital status, social security, employment and income status, smoking and alcohol use) were included. and medical characteristics (duration of HT diagnosis, medications used, presence of hypertension in the family, other chronic diseases) will be included.\n\nLife Findings Record Form: The researcher will measure the patient\'s blood pressure, oxygen saturation, pulse and respiratory rate, body temperature 10 minutes before and 10 minutes after the laughter yoga session and record them on this form.\n\nPittsburgh Sleep Quality Index (PSQI): The scale consists of 18 items and 7 components. The total PDQI score is the sum of the scores of these components and the total score takes a value between 0-21. A PDQI total score \\>5 indicates \'poor sleep quality\' and a PDQI total score \\<5 indicates \'good sleep quality\'. The Cronbach alpha reliability coefficient of the Turkish version of the scale was found to be 0.80.\n\nState and Trait Anxiety Inventory (STAI): The scale consists of two separate forms, a 20-item State Anxiety Scale and a 20-item Trait Anxiety Scale. The total score value obtained from the scales is between 20 and 80 points. Scores close to 80 points indicate a high level of anxiety. Scale reliability according to Kuder-Richardson reliability: 0.83 to 0.87 for Trait Anxiety Scale and 0.94 to 0.96 for State Anxiety Scale. Item reliability correlations were found between 0.34 and 0.72 for the Trait Anxiety Scale and between 0.42 and 0.85 for the State Anxiety Scale. In the scale, which measures momentary (temporary) anxiety at a reliable level, participants tick the most appropriate option from the options of "not at all", "a little", "a lot" or "completely" for each statement in the state anxiety scores. Positive scores (increasing the total anxiety score) are given for items; negative scores (decreasing the total anxiety score) are given for items. During the evaluation, a score between 1 (or -1) and 4 (or -4) is given for each item according to the positive or negative feature of the item and a constant of 50 is added to the total score to be obtained. The highest score is 80 and the lowest score is 20. The higher the total anxiety score, the higher the anxiety level of the respondent.\n\nHill-Bone Hypertension Treatment Compliance Scale: The four-point Likert-type scale (0=never, 1=sometimes, 2=most of the time and 3=always) consists of 14 items and has three sub-dimensions including interview, medical and nutrition. The scores that can be obtained from the scale vary between 0 (perfect agreement) and 42 (incompatible). As the score obtained from the scale increases, treatment compliance decreases. While the Cronbach alpha value of the original scale was found to be 0.84, the Cronbach alpha reliability coefficient of the Turkish version was found to be 0.83.\n\nLaughter Yoga Satisfaction Scale: In the first stage of the research, the scale developed by the researcher and the validity-reliability study will be used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with hypertension in the last one year\n* Those who volunteered to participate in the study\n* No problem preventing communication\n* No cognitive and mental problems\n* Not taking anxiolytics, antidepressants or sleeping pills\n* Individuals without an additional chronic disease that may affect breathing, such as heart failure or chronic obstructive pulmonary disease\n\nWill be included in the research.\n\nExclusion Criteria:\n\n* The patient wishes to leave the study voluntarily\n* Less than 80% participation of the patient in the laughter yoga programme\n* Failure of the patient to participate in follow-up assessments\n* The patient receives additional treatments during the study'}, 'identificationModule': {'nctId': 'NCT07148869', 'acronym': 'HT-Laughter', 'briefTitle': 'The Effect of Laughter Yoga Practice in Hypertension Patients', 'organization': {'class': 'OTHER', 'fullName': 'Kilis 7 Aralik University'}, 'officialTitle': 'The Effect of Laughter Yoga Practice on Anxiety, Sleep Quality, Treatment Compliance and Satisfaction in Hypertension Patients', 'orgStudyIdInfo': {'id': 'HASAN KALYONCU UNIVERSITY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'laughter yoga group', 'description': 'Patients will be divided into groups of at least 5 people according to the sample size. Laughter yoga sessions will be conducted under the leadership of the researcher in a suitable room / hall determined within the hospital. A total of 8 sessions will be applied, 2 sessions per week for 4 weeks, with each session lasting an average of 40 minutes.', 'interventionNames': ['Behavioral: LAUGHTER YOGA']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CONTROL GROUP', 'description': 'there will be no application to this group', 'interventionNames': ['Other: control group']}], 'interventions': [{'name': 'LAUGHTER YOGA', 'type': 'BEHAVIORAL', 'description': 'Patients will be divided into groups of at least 5 people according to the sample size. Laughter yoga sessions will be conducted under the leadership of the researcher in a suitable room / hall determined within the hospital. A total of 8 sessions will be applied, 2 sessions per week for 4 weeks, with each session lasting an average of 40 minutes.', 'armGroupLabels': ['laughter yoga group']}, {'name': 'control group', 'type': 'OTHER', 'description': 'there will be no application to this group', 'armGroupLabels': ['CONTROL GROUP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'facility': 'Hasan Kalyoncu University', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}], 'centralContacts': [{'name': 'GULSEN KARATAS', 'role': 'CONTACT', 'email': 'glsnkrts002@gmail.com', 'phone': '+905054846160'}], 'overallOfficials': [{'name': 'NURAN TOSUN, PROF.', 'role': 'STUDY_DIRECTOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'the study can be shared after publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kilis 7 Aralik University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hasan Kalyoncu University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'GÜLSEN KARATAŞ', 'investigatorAffiliation': 'Kilis 7 Aralik University'}}}}