Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:19 AM
Study NCT ID:
NCT07436832
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emotional Freedom Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-10-30', 'size': 113634, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-30T09:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'State Anxiety Scale mean score', 'timeFrame': 'Before intervention (baseline) and immediately after intervention (post-test)', 'description': 'Mean change in State Anxiety Scorefrom baseline to post-intervention (immediately after treatment), Minimum score: 20, Maximum score: 80, Higher scores indicate higher levels of state (situational) anxiety, Lower scores indicate lower levels of state anxiety.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['High Risk Pregnancy']}, 'descriptionModule': {'briefSummary': 'This study was conducted as a randomized controlled trial to examine the effect of the Emotional Freedom Technique on preoperative anxiety and postpartum depression in high-risk pregnant women who had decided to undergo planned cesarean delivery. Data were collected from women diagnosed with high-risk pregnancy who had made the decision for planned cesarean delivery in the last trimester of pregnancy. In the Emotional Freedom Technique group, the technique was applied during the preoperative period, while the standard care group received only standard care. The study was completed with 30 women in the Emotional Freedom Technique group and 32 women in the standard care group. The "Pregnant Introductory Information Form," the "State-Trait Anxiety Inventory," and the "Edinburgh Postnatal Depression Scale" were used as data collection tools. Pre-test and post-test applications of the scales were performed, and on the 21st day postpartum, the Edinburgh Postnatal Depression Scale was administered. For data analysis, descriptive statistics, independent samples t-test, paired samples t-test, ANOVA, and Pearson correlation analyses were used.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'pregnancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Participants meeting the following criteria will be included in the study:\n\nIdentified as at-risk pregnancies according to the Ministry of Health Risk Assessment Form,\n\nAble to speak and understand Turkish,\n\nAged between 18 and 45 years,\n\nHave a planned cesarean delivery decision,\n\nHave a gestational age of 36 weeks or more,\n\nHave a State Anxiety Inventory (STAI-State) mean score of 37 or higher,\n\nVoluntarily agree to participate in the study.\n\nExclusion Criteria\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\nPregnant women evaluated between March 1, 2024 and September 30, 2024 at Ankara Etlik City Hospital, Perinatology Clinic, who decline voluntary participation,\n\nPregnant women classified as low-risk according to the Ministry of Health Risk Assessment Form,\n\nYounger than 18 years or older than 45 years,\n\nThose who undergo vaginal delivery,\n\nPregnant women with a gestational age of 35 weeks or less,\n\nThose with a State Anxiety Inventory (STAI-State) mean score of 36 or lower,\n\nPregnant women with any psychiatric disorder or diagnosis,\n\nThose unable to speak or understand Turkish,\n\nParticipants who withdraw from the study at any stage at their own request.'}, 'identificationModule': {'nctId': 'NCT07436832', 'acronym': 'EFT', 'briefTitle': 'Emotional Freedom Technique', 'organization': {'class': 'OTHER', 'fullName': 'Mersin University'}, 'officialTitle': 'The Effect of Emotional Freedom Technique Applied to High-Risk Pregnant Women on Anxiety and Postpartum Depression: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2024/299'}, 'secondaryIdInfos': [{'id': 'Mersin University', 'type': 'OTHER', 'domain': 'Mersin University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'emotional freedom technique group', 'description': "A pregnant woman, who was scheduled for a high-risk cesarean section in the perinatology ward due to a high-risk pregnancy, was initially evaluated using the pregnancy information form and the scores obtained from the SSI. The woman's emotional score was assessed using the SSI scale: The researcher showed her the points to tap before the session. Then, a round of SSI was administered by the researcher and the woman. After the application, the woman was asked to evaluate her emotions on the SSI scale. The session ended if the scale score exceeded +7. For pregnant women who could not reach +7, the SSI round continued by creating new suggestion sentences according to their needs (until it reached +7). The SSI was administered to the woman in the last hour of the preoperative period. Postpartum, the woman was informed that she could perform the SSI she had been taught if she desired, and that if she did, she would inform the researcher of the number of times she had performed it. On the 2", 'interventionNames': ['Other: Emotional Freedom Tecnic']}, {'type': 'NO_INTERVENTION', 'label': 'standard care group', 'description': 'The researcher performing the intervention assigned the individuals to the groups, ensuring a safe randomization process by blinding them to their group. The researcher met with the women upon their admission to the Perinatology Unit, provided information about the study, and obtained their verbal consent. After the hospital preoperative preparations were completed, the researcher opened the envelope and acted according to the group information. Information was provided about the purpose, scope, and duration of the study, and informed consent forms were signed by the volunteer participants (Appendix 6). No other interventions were performed on the women in this group other than the consent forms and assessment tools. In the last hour before the surgery, the researcher again asked the women the questions on the SAC. On the 21st day following her delivery, the women were contacted by phone and asked the EPAD questions, and the study concluded.'}], 'interventions': [{'name': 'Emotional Freedom Tecnic', 'type': 'OTHER', 'description': 'Emotional Freedom Technique application to high-risk pregnant women', 'armGroupLabels': ['emotional freedom technique group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mersin', 'country': 'Turkey (Türkiye)', 'facility': 'mersin University', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared because of institutional data protection policies and participant privacy concerns.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mersin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Meltem Aydın Beşen', 'investigatorAffiliation': 'Mersin University'}}}}