Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-31 @ 10:19 PM
Study NCT ID:
NCT06980558
Status:
RECRUITING
Last Update Posted:
2025-05-20
First Post:
2025-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Progressive Muscle Exercises on Sleep in Urological Surgery
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2025-05-04', 'studyFirstSubmitQcDate': '2025-05-19', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Richard's Campbell sleep scale", 'timeFrame': '1 hour before surgery', 'description': "It was developed by Richards in 1987 and examines the previous night's sleep in 6 parameters: sleep depth, falling asleep, frequency of waking, duration of wakefulness, quality of sleep, noise level, and is scored between 100 'very appropriate' and '0' 'not appropriate'. The higher the score received from the scale, the higher the patient's sleep quality is considered."}], 'secondaryOutcomes': [{'measure': "Richard's Campbell sleep scale", 'timeFrame': 'the night before surgery', 'description': "It was developed by Richards in 1987 and examines the previous night's sleep in 6 parameters: sleep depth, falling asleep, frequency of waking, duration of wakefulness, quality of sleep, noise level, and is scored between 100 'very appropriate' and '0' 'not appropriate'. The higher the score received from the scale, the higher the patient's sleep quality is considered."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['urological Surgery', 'sleep quality'], 'conditions': ['Surgery', 'Sleep Quality', 'Sleep']}, 'descriptionModule': {'briefSummary': 'Patients undergoing urological surgery are usually elderly individuals and may experience sleep problems due to factors such as fear of death, anesthesia, and uncertainty. Insomnia can also cause problems such as delayed wound healing, increased pain, tension, and difficulty complying with treatment. This study aimed to improve sleep quality by performing gradual muscle exercises on patients undergoing urological surgery.', 'detailedDescription': "Urological surgery is a type of surgery that is usually performed on elderly individuals and can cause serious sleep problems in the pre- and post-operative period. While these patients experience sleep problems due to factors such as fear of death and uncertainty about anesthesia before surgery, significant decreases in sleep quality are observed after surgery due to reasons such as pain, anxiety and hospitalization. This sleeplessness can lead to many negative consequences such as delayed wound healing, increased pain, tension and difficulty in compliance with treatment. Sleep disorders also increase patients' stress and reduce their resistance. Progressive relaxation exercises (PGE) are a method that provides relaxation throughout the body by tensing and then relaxing all muscle groups in the body. This method is used as an effective nursing intervention, especially in the management of diseases and symptoms. This study aims to evaluate the effects of progressive relaxation exercises on sleep quality in patients undergoing urological surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patients must be over 18 and under 70 years old,\n\n * Patients must not have any visual or auditory problems that would prevent them from expressing their sleep status correctly and understanding the information provided,\n * Not have benefited from techniques such as meditation, hypnosis, yoga for up to 6 months before the study,\n * Not have a neurological or psychiatric disease,\n * Not have a sleep apnea syndrome/not have a sleep disorder diagnosis or are not receiving medical treatment for this purpose,\n * Patients must not have developed any complications within three days before, during, and after surgery,\n\nExclusion Criteria:\n\n* • Those with serious cognitive disorders\n\n * Those with severe psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT06980558', 'briefTitle': 'Effect of Progressive Muscle Exercises on Sleep in Urological Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Atlas University'}, 'officialTitle': 'Effect of Progressive Relaxation Exercises on Sleep Quality in Patients Undergoing Urological Surgery', 'orgStudyIdInfo': {'id': '05/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise group', 'description': 'The individual will be given a position where communication can be easily established and where he/she feels comfortable. The content of the progressive relaxation exercise (PGE) will be explained to the patient. The 30-minute PGE application will be provided with verbal warnings.', 'interventionNames': ['Other: Progressive relaxation exercises']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients will receive routine nursing care in the ward.'}], 'interventions': [{'name': 'Progressive relaxation exercises', 'type': 'OTHER', 'description': 'Sit or lie down comfortably and close your eyes.\n\n* Feel the rhythm of your breathing.\n* Breathe in through your nose and out through your mouth throughout the process.\n* Relax as much as you can.\n* Get rid of negative thoughts in your mind.\n* Stretch your hands by hanging your arms down to your sides, tighten your fists as much as you can and then open them and let them relax.', 'armGroupLabels': ['Exercise group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Atlas University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'cagla toprak, Dr.', 'role': 'CONTACT', 'email': 'cagla.toprak@atlas.edu.tr', 'phone': '532 799 78 14'}], 'overallOfficials': [{'name': 'naile akıncı, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fenerbahçe University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atlas University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Cagla Toprak', 'investigatorAffiliation': 'Atlas University'}}}}