Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 1:50 AM
Study NCT ID:
NCT06939894
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Drama Activities on Nursing Students' Attitudes Towards Pain Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-04-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-04-11', 'studyFirstSubmitQcDate': '2025-04-18', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain assessment attitudes of students', 'timeFrame': 'Day 0, month 1., and month 6.', 'description': "Students will be randomly assigned to the intervention and control groups. Students in the intervention group will fill out the introductory characteristics form and the nursing students' attitudes towards pain assessment scale after being assigned to the group and will then participate in drama activities prepared for pain assessment for one day. The students' attitudes towards pain assessment scale will be filled out again by the students one month after the intervention (November 2025) and approximately six months later (at 2025-2026 academic year). Students in the control group will fill out the introductory characteristics form and scale on the same dates as the experimental group without any intervention."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain Assessment']}, 'descriptionModule': {'briefSummary': "Title:\n\nThe Effect of Drama-Based Education on Nursing Students' Attitudes Toward Pain Assessment: A Randomized Controlled Trial\n\nAbstract:\n\nThis randomized controlled trial aims to investigate the effect of drama-based education on nursing students' attitudes toward pain assessment. The study will be conducted during the 2025-2026 academic year at Necmettin Erbakan University, Faculty of Nursing. A total of 52 second-year students who meet the inclusion criteria will be randomly assigned to intervention and control groups.\n\nThe intervention group will attend a one-day drama workshop involving role-play, improvisation, and reflection activities focused on pain assessment. The control group will not receive any intervention. Attitudes will be measured using a validated scale at three points: before the intervention, one month after, and six months after.\n\nData will be analyzed using SPSS with a significance level of p \\< 0.05. It is anticipated that the intervention group will show improved attitudes compared to the control group.\n\nThis study may provide evidence for integrating drama-based methods into nursing education to enhance students' sensitivity and competence in pain assessment.\n\nKeywords:\n\nNursing education, pain assessment, drama, student attitudes,", 'detailedDescription': "This study is designed as a randomized controlled trial using a pretest-posttest design to examine the effect of drama-based education on nursing students' attitudes toward pain assessment. The research will be conducted during the 2025-2026 academic year at the Faculty of Nursing, Necmettin Erbakan University (NEU), which offers education in nine nursing departments. The study population consists of second-year nursing students (n=160). The sample will include students whose native language is Turkish, who have not received any formal education in pain management, and who volunteer to participate. Sample size was calculated using G\\*Power 3.1.9.2, based on Cohen's conventional effect size (d=0.80, power=0.80, two sided), resulting in a total of 52 students (26 in each group), allowing for potential attrition.\n\nParticipants will be randomly assigned to intervention and control groups via random.org by an independent statistician. Data will be collected face-to-face using a Descriptive Information Form and the Attitudes of Nursing Students Toward Pain Assessment Scale. The intervention group will participate in a one-day drama-based workshop designed by a certified drama leader, focusing on pain assessment. The attitude scale will be administered before the intervention, one month later (November 2025), and approximately six months later (at 2025-2026 academic year). The control group will complete the same data collection tools at equivalent time points without receiving any intervention.\n\nDrama activities will follow the preparation, enactment, and reflection phases, utilizing techniques such as role-play, improvisation, and pantomime. The dependent variable is the mean attitude score toward pain assessment; the independent variable is the drama activity, while control variables include age, gender, knowledge of pain assessment methods and tools, prior education in pain management, and clinical experience with patients in pain. Data will be analyzed using SPSS software, applying descriptive statistics and appropriate parametric or non-parametric tests based on normality. Significance will be set at p\\<0.05.\n\nEthical approval will be obtained from the NEU Scientific Research Ethics Committee and the Faculty of Nursing. Written and verbal informed consent will be collected from all participants. Permission to use the attitude scale has been granted by the original authors. After data collection, the drama intervention will also be offered to the control group to ensure ethical balance.\n\nKeywords: Nursing education, pain assessment, drama-based intervention, student attitudes"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: The study group will consist of second-year students\n\n* the study sample will consist of students whose native language is Turkish,\n* who have not taken a course on pain management,\n* and who volunteer to participate in the study.\n\nExclusion Criteria:\n\n* students who wish to withdraw from research'}, 'identificationModule': {'nctId': 'NCT06939894', 'briefTitle': "The Effects of Drama Activities on Nursing Students' Attitudes Towards Pain Assessment", 'organization': {'class': 'OTHER', 'fullName': 'Necmettin Erbakan University'}, 'officialTitle': "The Effects of Drama Activities on Nursing Students' Attitudes Towards Pain Assessment: A Randomised Controlled Trial", 'orgStudyIdInfo': {'id': 'NEU-GB-OB-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'no intervention, usual curriculum.'}, {'type': 'EXPERIMENTAL', 'label': 'Drama', 'description': 'will take drama activities', 'interventionNames': ['Behavioral: Drama activities']}], 'interventions': [{'name': 'Drama activities', 'type': 'BEHAVIORAL', 'description': 'iintervention group will paticipate drrama activities aabout pain assessment of a patient.', 'armGroupLabels': ['Drama']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Meram', 'state': 'Konya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Gülden Basit', 'role': 'CONTACT', 'email': 'guldenbasit@gmail.com', 'phone': '+90 332 320 40 29'}], 'facility': 'Necmettin Erbakan University', 'geoPoint': {'lat': 37.82985, 'lon': 32.46777}}, {'city': 'Meram', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Gülden Basit', 'role': 'CONTACT', 'email': 'guldenbasit@gmail.com', 'phone': '(0 332) 320 40 29'}, {'role': 'CONTACT', 'phone': '(0 332) 320 40 29'}, {'name': 'Osman Basit', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Necmettin Erbakan University', 'geoPoint': {'lat': 37.82985, 'lon': 32.46777}}], 'centralContacts': [{'name': 'Gülden Basit, Assoc. Prof.', 'role': 'CONTACT', 'email': 'guldenbasit@gmail.com', 'phone': '0332-320-40-29'}], 'overallOfficials': [{'name': 'Gülden Basit', 'role': 'STUDY_CHAIR', 'affiliation': 'Necmettin Erbakan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Necmettin Erbakan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'Gulden Basit', 'investigatorAffiliation': 'Necmettin Erbakan University'}}}}