Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT04900194
Status:
COMPLETED
Last Update Posted:
2021-05-25
First Post:
2021-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Mindfulness-based Sexual Counseling on Sexual Distress in Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019529', 'term': 'Sexuality'}], 'ancestors': [{'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-23', 'studyFirstSubmitDate': '2021-05-19', 'studyFirstSubmitQcDate': '2021-05-23', 'lastUpdatePostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Female Sexual Distress', 'timeFrame': 'Change from Female Sexual Distress at 4 weeks', 'description': 'It is used to identify women with and without sexual dysfunction, evaluating subjective stress and psychological effects associated with sexual function. Responses to the items in the five-point Likert scale consist of never (0), rarely (1), sometimes (2), often (3), or always (4). The lowest score that can be obtained from the scale is 0, the highest score is 52. Higher scores indicate higher levels of sexual distress.'}], 'secondaryOutcomes': [{'measure': 'The Scale of Attitude towards Sexuality in Pregnancy', 'timeFrame': 'Change from Attitude towards Sexuality at 4 weeks', 'description': 'The items contain cognitive, affective and behavioral components of sexual attitude. The scale has three sub-dimensions; "Anxiety Towards Sexual Intercourse During Pregnancy", "Beliefs and Values Towards Sexuality During Pregnancy", "Confirming Sexuality During Pregnancy". The total score that can be obtained from the total score of the scale is the lowest 34 and the highest 170. The increase in the total score obtained from ATSPS indicates that the attitudes towards sexuality during pregnancy are positive, and the decrease in the total score indicates that the attitudes towards sexuality during pregnancy are negative.'}, {'measure': 'Body Image Worries in Pregnancy Scale', 'timeFrame': 'Change from Body Image Worries at 4 weeks', 'description': 'The scale consists of 4 sub-dimensions. Sub-dimensions of the scale Avoidance, Social worries, Worries about weight gain, Future worries, physical appearance concerns.The highest score to be obtained from the scale is 115, the lowest score is 23.An increase in the total score of the scale indicates that concerns about body image are high during pregnancy, while a decrease indicates that concerns about body image during pregnancy are low.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pregnancy', 'mindfulness', 'sexuality'], 'conditions': ['Counseling']}, 'referencesModule': {'references': [{'pmid': '32923929', 'type': 'RESULT', 'citation': 'Nezamnia M, Iravani M, Bargard MS, Latify M. Effectiveness of cognitive-behavioral therapy on sexual function and sexual self-efficacy in pregnant women: An RCT. Int J Reprod Biomed. 2020 Aug 19;18(8):625-636. doi: 10.18502/ijrm.v13i8.7504. eCollection 2020 Aug.'}, {'pmid': '18507718', 'type': 'RESULT', 'citation': 'Brotto LA, Basson R, Luria M. A mindfulness-based group psychoeducational intervention targeting sexual arousal disorder in women. J Sex Med. 2008 Jul;5(7):1646-59. doi: 10.1111/j.1743-6109.2008.00850.x.'}, {'pmid': '37294101', 'type': 'DERIVED', 'citation': 'Cengizhan SO, Ucar T. The Effect of Mindfulness-Based Sexual Counseling on Sexual Distress, Attitude Toward Sexuality, and Body Image Concerns in Pregnant Women: A Randomized Controlled Trial. J Midwifery Womens Health. 2023 Sep-Oct;68(5):611-618. doi: 10.1111/jmwh.13518. Epub 2023 Jun 9.'}]}, 'descriptionModule': {'briefSummary': 'The study was conducted in order to determine the effect of mindfulness-based sexual counseling on sexual distress, attitude towards sexuality and body image concerns in pregnant women. The research was planned in a randomized controlled experimental design.The sample consisted of the pregnant women who applied to the pregnant class at the time of the study and met the inclusion criteria. Female Sexual Distress Scale-Revised, Attitude towards Sexuality in Pregnancy Scale, Body Image Concerns During Pregnancy Scale were used. In the study, the pregnant women in the experimental group were given mindfulness-based sexual counseling by the researcher. Mindfulness-based sexual counseling was planned as 2 sessions per week for 4 weeks, in total 8 sessions. Each session lasted 30-40 minutes on average. First of all, Pregnancy Introduction Form, Attitude towards Sexuality in Pregnancy Scale, Female Sexual Distress Scale-Revised and Body Image Concerns in Pregnancy Scale were applied to the pregnant women in the experimental and control groups. The experimental group was given mindfulness-based sexual counseling for 4 weeks by the researcher. At the end of the mindfulness-based sexual counseling, the experimental group and the control group at the same time, were applied to the experimental group and the control group at the same time, the Female Sexual Distress Scale-Revised, Attitude towards Sexuality in Pregnancy Scale, and the Body Image Worries During Pregnancy Scale.', 'detailedDescription': 'The research was planned in a randomized controlled experimental design.The sample consisted of the pregnant women who applied to the pregnant class at the time of the study and met the inclusion criteria. In the power analysis used to determine the sample size, the 5% error level, the 95% confidence interval at the bilateral significance level, the 80% ability to represent the universe and the sexual distress mean score of 31.3 (standard deviation 10.9) in women. Assuming that 67 pregnant women were calculated for each group (67 experiments, 67 controls). Pregnancy Identification Form, Female Sexual Distress Scale-Revised, Attitude towards Sexuality in Pregnancy Scale, Body Image Concerns During Pregnancy Scale were used. In the study, the pregnant women in the experimental group were given mindfulness-based sexual counseling by the researcher. Mindfulness-based sexual counseling was planned as 2 sessions per week for 4 weeks, in total 8 sessions. Each session lasted 30-40 minutes on average. First of all, Pregnancy Introduction Form, Attitude towards Sexuality in Pregnancy Scale, Female Sexual Distress Scale-Revised and Body Image Concerns in Pregnancy Scale were applied to the pregnant women in the experimental and control groups. The experimental group was given mindfulness-based sexual counseling for 4 weeks by the researcher. At the end of the mindfulness-based sexual counseling, the experimental group and the control group at the same time, were applied to the experimental group and the control group at the same time, the Female Sexual Distress Scale-Revised, Attitude towards Sexuality in Pregnancy Scale, and the Body Image Worries During Pregnancy Scale.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Communicating,\n* Over the age of 18,\n* Pregnancy week between 10-28 weeks,\n* Scoring 11.5 points and above according to the Female Sexual Distress Scale-Revised,\n\nExclusion Criteria:\n\n* Sexual distress before pregnancy,\n* Pregnant women with psychological diagnosis according to records.'}, 'identificationModule': {'nctId': 'NCT04900194', 'briefTitle': 'The Effect of Mindfulness-based Sexual Counseling on Sexual Distress in Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Inonu University'}, 'officialTitle': 'The Effect of Mindfulness-based Sexual Counseling on Sexual Distress, Attitudes Towards Sexuality and Body Image Concerns in Pregnant Women', 'orgStudyIdInfo': {'id': '2020-786'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MBSC group', 'description': 'counseling group', 'interventionNames': ['Behavioral: mindfulness-based sexual counseling']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'standard care group'}], 'interventions': [{'name': 'mindfulness-based sexual counseling', 'type': 'BEHAVIORAL', 'description': "Mindfulness-based sexual counseling was planned as 2 sessions per week for 4 weeks, in total 8 sessions. Each session lasted 30-40 minutes on average. The sessions were carried out individually by determining the appropriate days of pregnant women in the pregnancy class.In the study, the meditation techniques of the Mindfulness Therapy constituted the backbone/framework of the psychoeducation program. Body and breath, body scanning, mindfulness movement and three-minute respiration techniques were practiced during the psychoeducation program, practically every session in accordance with the researchers' directives.", 'armGroupLabels': ['MBSC group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Malatya', 'state': 'Merkez', 'country': 'Turkey (Türkiye)', 'facility': 'Faculty of Health Science', 'geoPoint': {'lat': 38.35018, 'lon': 38.31667}}], 'overallOfficials': [{'name': 'Sıdıka Özlem Cengizhan, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inonu University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'individual participant data were not shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inonu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sıdıka Özlem CENGİZHAN', 'investigatorAffiliation': 'Inonu University'}}}}