Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:28 AM
Study NCT ID:
NCT07461051
Status:
COMPLETED
Last Update Posted:
2026-03-10
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Foot Bath Therapy on Premenstrual Syndrome Symptoms, Quality of Life, and Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011293', 'term': 'Premenstrual Syndrome'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study was conducted using a randomized controlled pretest-posttest experimental design with a follow-up assessment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Personal Information Form', 'timeFrame': 'Pretest assessments were administered to all participants in both groups before the intervention.', 'description': "The Personal Information Form was developed by the researchers to determine the participants' sociodemographic and menstrual characteristics."}, {'measure': 'Premenstrual Syndrome Scale (PMSS)', 'timeFrame': '* "Baseline 1" * "3 months later" * "4 weeks later" * "approximately 4months"', 'description': 'The Premenstrual Syndrome Scale (PMSS) was developed by Gençdoğan (2006) based on DSM-III and DSM-IV-TR diagnostic criteria to assess the severity of premenstrual symptoms. The scale consists of 44 items and is structured as a 5-point Likert-type instrument. Each item is rated between "Never" (1 point) and "Always" (5 points), and higher total scores indicate greater symptom severity. The scale includes nine subdimensions: depressive mood, anxiety, fatigue, irritability, depressive thoughts, pain, appetite changes, sleep changes, and bloating.'}, {'measure': 'Visual Analog Scale (VAS)', 'timeFrame': '* "Baseline 1" * "3 months later" * "4 weeks later" * "Approximately 4months"', 'description': 'The Visual Analog Scale (VAS) is a one-dimensional measurement tool used to assess pain intensity and was first developed by Hayes and Patterson (1921). The scale consists of a 10-cm (100 mm) horizontal or vertical line anchored by "No pain" at one end and "Unbearable pain" at the other. Participants are asked to mark the point that best represents their perceived pain intensity. The VAS is widely accepted as a reliable and sensitive tool for measuring pain severity in clinical research (Ahearn, 1997).'}, {'measure': 'SF-36 Short Form', 'timeFrame': '* "Baseline 1" * "3 months later" * "4 weeks later" * "Approximately 4months"', 'description': 'The SF-36 is a 36-item self-report instrument developed to evaluate health-related quality of life. The scale measures eight domains: physical functioning, role limitations due to physical problems, bodily pain, general health perception, energy/fatigue, social functioning, role limitations due to emotional problems, and mental well-being. Scores are calculated according to standardized scoring procedures, with higher scores indicating better quality of life. The Turkish validity and reliability of the scale were established by Demiral et al. (2006).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Foot bath', 'Premenstrual Syndrome', 'Quality of life', 'pain'], 'conditions': ['Premenstrual Syndrome']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Demiral, Y., Ergor, G., Unal, B., Semin, S., Akvardar, Y., Kivircik, B., & Alper, Z. (2006). Normative data and discriminative properties of short form 36 (SF-36) in Turkish urban population. BMC Public Health, 6, 247. https://doi.org/10.1186/1471-2458-6-247'}, {'type': 'RESULT', 'citation': 'Ahearn, E. P. (1997). The use of visual analog scales in mood disorders: A critical review. Journal of Psychiatric Research, 31(5), 569-579.'}, {'type': 'RESULT', 'citation': 'Gençdoğan, B. (2006). Development of a scale for measuring premenstrual syndrome symptoms. Turkish Psychological Counseling and Guidance Journal, 3(26), 51-58.'}]}, 'descriptionModule': {'briefSummary': 'The study was conducted as a randomized controlled trial to evaluate the effects of foot bath application on symptom severity, quality of life, and pain levels in women with premenstrual syndrome. The research was carried out with 92 midwifery students. While foot bath therapy was applied to the experimental group, no intervention was performed in the control group. Data were collected through face-to-face interviews using the Personal Information Form, Premenstrual Symptom Scale, Visual Analog Scale, and SF-36 Quality of Life Scale.', 'detailedDescription': 'Study Design and Participants\n\nThis study was designed as a prospective randomized controlled trial including pretest, posttest, and follow-up measurements. The study population consisted of midwifery students studying at the Faculty of Health Sciences at X University who reported symptoms of premenstrual syndrome (PMS). The sample size was calculated using the G\\*Power 3.1.9.7 software. Based on a medium effect size (f = 0.25), repeated measures ANOVA with two groups and three measurements, a significance level of 5% (α = 0.05), a correlation coefficient between repeated measurements of 0.50, and 80% statistical power (1-β = 0.80), the minimum required sample size was determined as 86 participants. The study was completed with 92 participants (Experimental group: 46, Control group: 46).\n\nThe study was conducted over three consecutive menstrual cycles, and data were collected at three different time points: before the intervention, at the end of the third menstrual cycle, and four weeks after completion of the intervention.\n\nIntervention (Foot Bath Application)\n\nParticipants in the experimental group received standardized education regarding the foot bath application, and the necessary materials were provided. Participants were instructed to soak their feet in water at a temperature of 38-42 °C for 20 minutes daily during the luteal phase (7-10 days before menstruation) for three consecutive menstrual cycles. Compliance with the intervention was monitored using a daily follow-up chart, and participants received reminder messages each evening. The foot bath procedure included cleaning the feet, preparing water at the appropriate temperature, verifying the temperature using a thermometer, immersing the feet in water for the specified duration, and drying the feet after the procedure. Outcome measurements were repeated at the end of each menstrual cycle and four weeks after completion of the intervention.\n\nControl Group\n\nNo intervention was applied to the control group, and participants were only followed throughout their menstrual cycles. Data were collected from the control group at the same time points as the experimental group (pretest, end of the third cycle, and four weeks after the intervention). After completion of the study, control group participants who requested the foot bath intervention were provided with the necessary materials in accordance with ethical principles.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women with premenstrual syndrome (PMS)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 and 25 years of age\n* Having no chronic disease\n* Having a symptom severity score of 5 or higher according to the VAS,\n* Voluntarily agreeing to participate in the study.\n\nExclusion Criteria:\n\n* Psychiatric disorder\n* Secondary dysmenorrhea.'}, 'identificationModule': {'nctId': 'NCT07461051', 'briefTitle': 'Effects of Foot Bath Therapy on Premenstrual Syndrome Symptoms, Quality of Life, and Pain', 'organization': {'class': 'OTHER', 'fullName': 'Inonu University'}, 'officialTitle': 'The Effects of Footbath on Premenstrual Syndrome Symptoms, Quality of Life, and Pain: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '2024/253'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Group 1 Foot bath therapy', 'description': 'Foot bath therapy', 'interventionNames': ['Other: Foot bath therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Group 2'}], 'interventions': [{'name': 'Foot bath therapy', 'type': 'OTHER', 'description': 'Foot bath therapy was applied during the luteal phase of three menstrual cycles.', 'armGroupLabels': ['Experimental: Group 1 Foot bath therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04100', 'city': 'Ağrı', 'state': 'Ağrı', 'country': 'Turkey (Türkiye)', 'facility': 'İnonü Universty', 'geoPoint': {'lat': 39.71467, 'lon': 43.04015}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "we don't share individual participant data with other researchers"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inonu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asistant Professor', 'investigatorFullName': 'nurten özçalkap', 'investigatorAffiliation': 'Inonu University'}}}}