Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 3:51 AM
Study NCT ID:
NCT07412093
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Progressive Relaxation Exercises and Planned Education on Menopausal Symptoms, Perceived Stress, and Anxiety in Menopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001326', 'term': 'Autogenic Training'}], 'ancestors': [{'id': 'D006990', 'term': 'Hypnosis'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2026-01-29', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived Stress Scale', 'timeFrame': 'Beginning', 'description': 'The scale consists of 10 items and is evaluated based on a total score. The scale is scored on a scale of 1-5. The total score ranges from 10 to 50, and an increase in the score indicates an increase in perceived stress level. The scale is assessed before any training or relaxation exercises during the initial encounter with women.'}, {'measure': 'Beck Anxiety Scale', 'timeFrame': 'Beginning', 'description': "The scale ranges from a minimum of 0 to a maximum of 63 points. However, based on the scores obtained on the scale, patients' anxiety levels are classified as follows: 0-7 points is low, 8-15 points is mild, 16-25 points is moderate, and 26-63 points is high anxiety. A high score indicates that the individual is experiencing a high level of anxiety.The scale is assessed before any training or relaxation exercises during the initial encounter with women."}, {'measure': 'Menopause Symptom Assessment Scale', 'timeFrame': 'Beginning', 'description': 'The scale consists of 11 items and 3 subscales. An increase in the total score obtained from the scale indicates an increase in the severity of complaints and, consequently, a negative impact on quality of life. The lowest possible score on the entire scale is 0, and the highest is 44.The scale is assessed before any training or relaxation exercises during the initial encounter with women.'}], 'secondaryOutcomes': [{'measure': 'Perceived Stress Scale', 'timeFrame': 'One month after relaxation exercises and planned training practices', 'description': 'The scale consists of 10 items and is evaluated based on a total score. The scale is scored on a scale of 1-5. The total score ranges from 10 to 50, and an increase in the score indicates an increase in perceived stress level. The scale is administered to the women again one month after the planned training and relaxation exercises are implemented.'}, {'measure': 'Beck Anxiety Scale', 'timeFrame': 'One month after relaxation exercises and planned training practices', 'description': "Description: The scale ranges from a minimum of 0 to a maximum of 63 points. However, based on the scores obtained on the scale, patients' anxiety levels are classified as follows: 0-7 points is low, 8-15 points is mild, 16-25 points is moderate, and 26-63 points is high anxiety. A high score indicates that the individual is experiencing a high level of anxiety.The scale is administered to the women again one month after the planned training and relaxation exercises are implemented."}, {'measure': 'Menopause Symptom Assessment Scale', 'timeFrame': 'One month after relaxation exercises and planned training practices', 'description': 'Description: The scale consists of 11 items and 3 subscales. An increase in the total score obtained from the scale indicates an increase in the severity of complaints and, consequently, a negative impact on quality of life. The lowest possible score on the entire scale is 0, and the highest is 44.The scale is administered to the women again one month after the planned training and relaxation exercises are implemented.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Menopause', 'Symptom', 'Exercise', 'Anxiety', 'Stress', 'Education'], 'conditions': ['Menopause', 'Menopausal Symptoms', 'Perceived Stress', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'The Effect of Progressive Relaxation Exercises and Planned Education on Menopausal Symptoms, Perceived Stress, and Anxiety in Menopausal Women', 'detailedDescription': 'The study will be conducted with women who are in the menopausal period. Data will be collected using the Personal Information Form, Menopause Symptoms Assessment Scale, Perceived Stress Scale and Beck Anxiety Scale.\n\nStudy; It will be divided into three groups: progressive relaxation exercise group, planned training group and control group. A total of 144 participants, 48 for each group, were planned to be included in the sample.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '49 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Not having communication and perception problems\n* Being in menopause\n* Not having a mental illness diagnosis\n* Voluntary participation in the study\n\nExclusion Criteria:\n\n* Having communication and perception problems\n* Not being in menopause\n* Not having a mental illness diagnosis\n* Not being a volunteer to participate in the study'}, 'identificationModule': {'nctId': 'NCT07412093', 'briefTitle': 'The Effect of Progressive Relaxation Exercises and Planned Education on Menopausal Symptoms, Perceived Stress, and Anxiety in Menopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Cumhuriyet University'}, 'officialTitle': 'The Effect of Progressive Relaxation Exercises and Planned Education on Menopausal Symptoms, Perceived Stress, and Anxiety in Menopausal Women', 'orgStudyIdInfo': {'id': 'TR SİVAS 08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'progressive relaxation exercise', 'description': 'Progressive relaxation exercises combine deep breathing with the contraction and relaxation of muscle groups such as the hands, arms, upper arms, feet, lower legs and calves, hips, abdomen and lower back, chest, face, shoulders and back, neck, jaw, lips, eyes, and forehead. After taking a deep breath, the muscles are tensed, this tension is maintained for 5-10 seconds, and then the muscles are relaxed (10-20 seconds). When a muscle is tense, the deeper the tension, the deeper the relaxation will be when it is released. During the exercise, the individual is asked to continue breathing in slowly and deeply through the nose and exhaling through the mouth.', 'interventionNames': ['Behavioral: Progressive relaxation']}, {'type': 'EXPERIMENTAL', 'label': 'planned education', 'description': 'The topics covered in the educational content include: What menopause is, causes of menopause, factors affecting the onset of menopause, complaints during menopause, general symptoms of menopause, nutrition during menopause, sleep during menopause, emotional problems during menopause, and coping strategies.', 'interventionNames': ['Other: Planned education']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'The control group will not receive any intervention; only the Perceived Stress Scale, Menopause Symptom Assessment Scale, and Beck Anxiety Scale will be administered as pre-tests and post-tests.'}], 'interventions': [{'name': 'Progressive relaxation', 'type': 'BEHAVIORAL', 'description': 'Progressive relaxation exercises begin with breathing exercises and continue with muscle stretching and relaxation exercises, lasting an average of 30 minutes.', 'armGroupLabels': ['progressive relaxation exercise']}, {'name': 'Planned education', 'type': 'OTHER', 'description': 'The training group will receive pre-planned training in accordance with the literature, delivered as group training in line with adult learning principles.', 'armGroupLabels': ['planned education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00058', 'city': 'Sivas', 'state': 'Merkez', 'country': 'Turkey (Türkiye)', 'facility': 'Sivas Cumhuriyet University', 'geoPoint': {'lat': 39.74833, 'lon': 37.01611}}], 'overallOfficials': [{'name': 'Sukran Ertekin Pinar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cumhuriyet University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cumhuriyet University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Sukran Ertekin Pinar', 'investigatorAffiliation': 'Cumhuriyet University'}}}}