Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-06 @ 5:05 AM
Study NCT ID:
NCT07451756
Status:
COMPLETED
Last Update Posted:
2026-03-05
First Post:
2026-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Pranayama Breathing Technique on Stress Level, Sleep Quality, and Quality of Life Among Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'In elderly individuals, the control group received no intervention, while the Pranayama group underwent breathing techniques. Data were collected by the researcher from both groups at weeks 0, 4, and 8 using relevant scales.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparison of respiratory technique applied to the intervention group with that applied to the control group in elderly individuals.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-02-24', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sociodemographic and Aging-Related Characteristics Data Form', 'timeFrame': '0. Week', 'description': 'This form, collected from all participants during the initial interview, includes questions about age, gender, height, weight, marital status, education level, social security status, socioeconomic status, presence of chronic diseases, use of assistive devices, contact with family and friends, and length of stay in a nursing home. It was developed by the researchers through a literature review.'}], 'secondaryOutcomes': [{'measure': 'Perceived Stress Scale-PSS', 'timeFrame': '0., 4. and 8. weeks', 'description': "The PSS, in its original form, consists of 14 items. In addition, shorter versions with 10 and 4 items are also commonly used in the literature. The scale, which operates using a Likert-type rating system, measures individuals' perception of stress in specific situations. A higher score on the scale indicates that the individual perceives a higher level of stress."}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '0.,4. and 8. weeks', 'description': "The Pittsburgh Sleep Quality Index (PSQI) is a self-reported measurement tool developed by Buysse et al. in 1989 to assess individuals' sleep quality. This index aims to evaluate individuals' sleep patterns and quality over the past month."}, {'measure': 'World Health Organization Quality of Life Module for Older People (WHOQOL-OLD)', 'timeFrame': '0., 4. and 8. weeks', 'description': 'Developed in 2005, following the WHOQOL methodology developed by the World Health Organization, the WHOQOL-OLD module is designed to measure the quality of life of older individuals, taking into account their specific needs. The scale consists of 24 items and is composed of six sub-dimensions under the headings of Sensory Abilities, Autonomy, Satisfaction with Past, Present and Future Activities, Social Participation, Death and Dying, and Intimacy.'}, {'measure': 'World Health Organization Quality of Life Scale (WHO-8 EUROHIS)', 'timeFrame': '0., 4. and 8. weeks', 'description': "The WHO-8 EUROHIS is an eight-item scale developed to quickly and effectively measure individuals' overall quality of life. These items are chosen to represent the four core areas of the WHOQOL-BREF (physical health, psychological well-being, social relationships, and environmental conditions). Each item on the scale is answered using a 5-point Likert scale, with higher scores reflecting a better quality of life."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pranayama breathing technique', 'Older adults', 'Nursing home', 'Perceived stress', 'Sleep quality', 'Guality of life'], 'conditions': ['Individuals Aged 60 and Over', 'Individuals Who Are Physically and Mentally Suitable to Practice Pranayama Breathing Technique', 'Individuals Without a Malignant Respiratory System Disease (Such as Bronchial and Lung Cancer)', 'Individuals Without a Pathological Condition Affecting Their Level of Consciousness and Concentration', 'Those Who Voluntarily Agreed to Participate in the Research']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Urvashi Bhattacharya AD. Efficacy of advanced allied interventions for dyspnoea, exercise capacity, and quality of life among the geriatric population: A Literature Review. Journal of Clinical and Diagnostic Research. 2024;18:YE05-YE8. Doi: 10.7860/JCDR/2024/68354.19276.'}, {'type': 'BACKGROUND', 'citation': 'Mandlik GV, Siopis G, Nguyen B, Ding D, Edwards KM. Effect of a single session of yoga and meditation on stress reactivity: A systematic review. Stress and Health. 2024;40. doi: 10.1002/smi.3324.'}, {'type': 'BACKGROUND', 'citation': 'Nalbant G, Hassanein ZM, Lewis S, Chattopadhyay K. Content, structure, and delivery characteristics of yoga interventions for managing hypertension: A systematic review and meta-analysis of randomized controlled trials. Frontiers in Public Health. 2022;10:846231. doi: 10.3389/fpubh.2022.846231.'}, {'type': 'BACKGROUND', 'citation': 'Taneja MK. Presbycusis. Indian Journal of Otology. 2021;27:121-3. doi: 10.4103/indianjotol.indianjotol_165_21.'}, {'type': 'BACKGROUND', 'citation': 'Campanelli S, Tort ABL, Lobão-Soares B. Pranayamas and their neurophysiological effects. International Journal of Yoga. 2020;13:183-92. doi: 10.4103/ijoy.IJOY_91_19.'}, {'type': 'BACKGROUND', 'citation': 'İlter SM, Ovayolu Ö. Pranayama and nursing. Holistic Nursing Practice. 2021;35:29-33. doi: 10.1097/HNP.0000000000000421.'}, {'type': 'BACKGROUND', 'citation': 'Muhammad T, Lee S, Pai M, Mandal B. Association between sleep quality, sleep duration, and physical frailty among adults aged 50 years and older in India. BMCPublicHealth. 2024;24:3120. doi: 10.1186/s12889-024-20606-6.'}, {'type': 'BACKGROUND', 'citation': 'Wang Z, Zeng Z. Association between personality characteristics and sleep quality among Chinese middle-aged and older adults: evidence from China family panel studies. BMC Public Health. 2023;23:2427. doi: 10.1186/s12889-023-17352-6.'}, {'type': 'BACKGROUND', 'citation': 'Zhang D, Ruan H, Gao MG, Chen F, Li S. Stressful life events and subjectively rated sleep quality among older adults in China: the roles of positive and negative attitudes towards ageing. Ageing & Society. 2022:1-19. doi: 10.1017/S0144686X22001222.'}, {'type': 'BACKGROUND', 'citation': 'Demir OB, Şimşek ÇK, Çekmece Ç, Şen PN, Genç SG, Keskin C, et al. The effect of online mat pilates exercises on quality of life, depression, and sleep quality in female university students during the COVID-19 pandemic. Istanbul Gelisim University Journal of Health Sciences. 2023:625-35. doi:10.38079/igusabder.1031574.'}, {'type': 'BACKGROUND', 'citation': 'Duman İ, Ceyhan Ö, Taşcı S. Use of aromatherapy in elderly individuals. Mersin University Faculty of Medicine Lokman Hekim Journal of Medical History and Folkloric Medicine. 2024;14(3):441-9. doi: 10.31020/mutftd.1510870.'}, {'type': 'BACKGROUND', 'citation': 'WHO. Ageing and health 2024 [Available from: https://www.who.int/news-room/fact-sheets/detail/ageing-and-health.'}, {'type': 'BACKGROUND', 'citation': 'Kwon Y. YAP/TAZ as molecular targets in skeletal muscle atrophy and osteoporosis. Aging and disease. 2024;16:299. doi: 10.14336/AD.2024.0306.'}]}, 'descriptionModule': {'briefSummary': 'Aging is associated with progressive tissue deterioration resulting from a continuous decline in the ability to renew homeostatic cell regeneration and replace cells lost during tissue damage. Biological aging arises from the accumulation of molecular and cellular damage over time. This condition leads to a gradual decline in physical and cognitive capacity, causing an increase in morbidity and mortality rates. These non-linear and inconsistent changes are linked more to lifestyle than to chronological age. Rather than biological changes, the fact that aging is often associated with other life transitions such as retirement, the death of friends and partners, and a decline in living standards indicates that the diversity observed in old age is not random.\n\nIn the aging process where individuals face various physical, mental, and social changes; problems such as stress, sleep issues, and reduced quality of life are among the commonly encountered situations that negatively affect the life satisfaction and quality of life of elderly individuals. Alongside modern medicine, the use of traditional and complementary practices has been reported to have positive effects on the health of elderly individuals.\n\nThis study was planned as a randomized controlled trial to examine the effects of the pranayama breathing technique applied to elderly individuals on stress levels, sleep, and quality of life.', 'detailedDescription': "With age, problems such as chronic stress and sleep disorders increase, and quality of life decreases. High stress levels negatively affect the overall quality of life of elderly individuals. Factors such as chronic illnesses, economic difficulties, loneliness, and dependency can increase stress levels in the elderly. This situation leads to physical and psychological health problems, thereby reducing quality of life. On the other hand, stress management is more successful in individuals with a good quality of life. Social support networks, a good standard of living, and a healthy environment can mitigate the effects of stress.\n\nStress directly affects sleep quality. Specifically, an increase in stress hormones can cause difficulties in falling asleep and maintaining sleep. This can lead to common sleep disorders such as insomnia in elderly individuals. Poor-quality sleep reduces stress tolerance. Insufficient and irregular sleep can weaken individuals' coping skills with stress and intensify the stress cycle. Good sleep quality supports physical recovery, strengthens mental functions, and enhances overall quality of life. Sleep disorders, on the other hand, lead to physical discomfort and psychological problems, negatively affecting quality of life.\n\nPranayama, a breath exercise technique of Indian origin that aims to balance the mind and body, is translated as 'breath science, breath control, voluntary respiration'. In Sanskrit, it consists of the words 'prana' meaning 'life force, vital energy, vitality' and 'yama' meaning 'to control'. According to yoga, an ancient way of life in Indian science, when an individual learns to control the life force, they can also gain control over the body, mind, and emotions. There are studies reporting that pranayama breathing exercises applied to elderly individuals have positive effects on stress levels, sleep, and quality of life.\n\nDependent Variables: Scores obtained from the Perceived Stress Scale (PSS), Pittsburgh Sleep Quality Index (PSQI), WHO Quality of Life Module for Older Adults (WHOQOL-OLD), and WHO-8 Quality of Life (WHO-8 EUROHIS) scales.\n\nIndependent Variables: Participants' descriptive characteristics such as age, gender, height, weight, marital status, educational status, social security status, socioeconomic status, presence of chronic disease, use of assistive devices, frequency of meeting with family and friends, and length of stay in the nursing home.\n\nThis research was conducted in two different nursing homes affiliated with the Family and Social Services Directorate of a province.\n\nThe research population consisted of a total of 156 elderly individuals in the two nursing homes. In the study conducted by Erdoğan Yüce in 2019, an effect size of 1.03 was calculated, with a margin of error of 0.05 and a power of 95%, resulting in n=26 elderly individuals from each group. Ninety elderly individuals who met the study criteria and volunteered were randomly assigned to groups of 45 Pranayama and 45 Control using Randomizer.org.\n\nDue to situations such as withdrawal from the study, death, or transfer to another institution, the study was completed with a total of 74 individuals: 34 in the pranayama group and 40 in the control group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Being 60 years of age or older\n* Individuals who are physically and mentally suitable to practice Pranayama breathing technique\n* Individuals without a malignant disease of the respiratory system (such as bronchial and lung cancer)\n* Individuals without a pathological condition affecting their level of consciousness and concentration\n* Those who voluntarily agree to participate in the research\n* Individuals who do not have communication problems and who cooperate in the practices required by the study\n\nExclusion Criteria:\n\n* Individuals with advanced cardiovascular disease or uncontrolled hypertension\n* Individuals who are physically and cognitively unsuitable for practicing Pranayama breathing techniques\n* Individuals with malignant respiratory system diseases (such as bronchial and lung cancer)\n* Individuals with pathological conditions affecting consciousness and concentration (dementia, Alzheimer's, or other serious cognitive impairments)\n* Individuals who did not regularly participate in Pranayama breathing techniques during the study period\n* Individuals who developed a serious health problem during the research period"}, 'identificationModule': {'nctId': 'NCT07451756', 'briefTitle': 'Effects of Pranayama Breathing Technique on Stress Level, Sleep Quality, and Quality of Life Among Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Namik Kemal University'}, 'officialTitle': 'Effects of Pranayama Breathing Technique on Stress Level, Sleep Quality, and Quality of Life Among Older Adults', 'orgStudyIdInfo': {'id': 'TNKU-HSAARSLAN-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Elderly individuals who do not receive intervention', 'description': 'Control group'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'The Effects of Pranayama Breathing Technique Applied to the Elderly', 'description': 'The pranayama group received Ujjayi, Nadi Shodhana, and Sama Vritti pranayama techniques, administered face-to-face by the researcher in groups of 6-7 participants for 15-20 minutes before lunch over 8 weeks.', 'interventionNames': ['Behavioral: Pranayama group']}], 'interventions': [{'name': 'Pranayama group', 'type': 'BEHAVIORAL', 'otherNames': ['Intervention Group'], 'description': 'The pranayama group received Ujjayi, Nadi Shodhana, and Sama Vritti pranayama techniques, administered face-to-face by the researcher in groups of 6-7 participants for 15-20 minutes before lunch over 8 weeks. The control group did not receive any intervention. Data were collected from both groups at weeks 0, 4th, and 8th using the Perceived Stress Scale (PSS), Pittsburgh Sleep Quality Index (PSQI), World Health Organization Quality of Life Module for the Elderly (WHOQOL-OLD) and WHO-8 EUROHIS Quality of Life Scale.', 'armGroupLabels': ['The Effects of Pranayama Breathing Technique Applied to the Elderly']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tekirdağ', 'country': 'Turkey (Türkiye)', 'facility': 'Nursing home', 'geoPoint': {'lat': 40.9781, 'lon': 27.51101}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Namik Kemal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer, PhD', 'investigatorFullName': 'Hatice Sevil ARSLAN', 'investigatorAffiliation': 'Namik Kemal University'}}}}