NCT05595759

Brief Summary

This study was planned as a randomized controlled trial in order to determine the effect of creative drama training for alcohol-substance dependent male patients on their attitudes towards violence against women.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

September 27, 2022

Last Update Submit

October 23, 2022

Conditions

Woman AbuseAddictionViolenceMen

Keywords

ViolenceWomenAddictionCreative drama

Outcome Measures

Primary Outcomes (2)

  • Pretest final test scores on violence against women

    Developed by Yalçın Kanbay in 2016, it is a 5-piece Likert type measurement tool consisting of two factors and 30 items. The scale has two sub-dimensions: "attitudes towards the body" and "attitudes towards identity". The total score of the scale is obtained by collecting the scores from two factors. On the scale, there are five answer options. In the scoring of the scale, each question is scored between 1-5. The high scores indicate that they are against violence against women, while the low scores indicate that they are not against violence against women. From the general scale, the lowest score is 30 and the highest score is 150. Kanbay found the Cronbach α value of the scale 0.86 for the overall scale. It is stated that the scale can be applied to individuals with at least primary school graduation and age between 15-65 years of age.

    10 day

  • Pretest final test scores

    Developed by Yalçın Kanbay in 2016, it is a 5-piece Likert type measurement tool consisting of two factors and 30 items. The scale has two sub-dimensions: "attitudes towards the body" and "attitudes towards identity". The total score of the scale is obtained by collecting the scores from two factors. On the scale, there are five answer options. In the scoring of the scale, each question is scored between 1-5. The high scores indicate that they are against violence against women, while the low scores indicate that they are not against violence against women. From the general scale, the lowest score is 30 and the highest score is 150. Kanbay found the Cronbach α value of the scale 0.86 for the overall scale. It is stated that the scale can be applied to individuals with at least primary school graduation and age between 15-65 years of age.

    10 days

Study Arms (2)

Male patients with a diagnosis of alcohol and substance abuse

EXPERIMENTAL

Male patients with a diagnosis of alcohol and substance abuse

Other: Violence against women education supported by creative drama

Routine service operation

OTHER

Male patients with a diagnosis of alcohol and substance abuse

Other: Routine service operation

Interventions

Violence against women education supported by creative dramaOTHER

Violence against women supported by creative drama training will be applied to male patients diagnosed with addiction every day for 5 days.

Male patients with a diagnosis of alcohol and substance abuse
Routine service operationOTHER

No additional training will be applied to the control group and SAMBA trainings in the service operation will be applied.

Routine service operation

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Literate,
  • Have reached the age of 18,
  • do not have an acute psychotic illness,
  • Patients without symptoms of delirium tremens or intense withdrawal made up the study group of this study.

You may not qualify if:

  • Illiterate,Woman,
  • Have an acute psychotic illness,
  • Delirium tremens or those with symptoms of intense withdrawal,
  • Patients who did not agree to participate in the study were not included in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health and Diseases Hospital

Bolu, 14100, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • ASAM. (2022, July 5). What is the definition of addiction? . File:///C:/Users/Lenovo/Desktop/B0209701-2099-441a-92c3-Eb60c4a387cb.Pdf.

    BACKGROUND

  • Bacchus LJ, Ranganathan M, Watts C, Devries K. Recent intimate partner violence against women and health: a systematic review and meta-analysis of cohort studies. BMJ Open. 2018 Jul 28;8(7):e019995. doi: 10.1136/bmjopen-2017-019995.

    PMID: 30056376BACKGROUND

  • Aksoy, Y. D., Nacar, G., & Taşhan, S. T. (2018). Examine the attitudes toward spouse violence of health sciences faculty students Sağlık bilimleri fakültesi öğrencilerinin eş tarafından uygulanan şiddete ilişkin tutumları. Journal of Human Sciences, 15(2), 919-930

    RESULT

  • Tok HH, Kesgin MT. Effect of drama-education for alcohol/substance user on attitudes toward violence against women: randomized controlled design. BMC Public Health. 2025 May 15;25(1):1781. doi: 10.1186/s12889-025-23012-8.

    PMID: 40375196DERIVED

MeSH Terms

Conditions

Behavior, AddictiveMultiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehaviorMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Study Officials

  • hümeyra Hançer tok, msc

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

hülya ensari, doç.

CONTACT

3742752525hulyaensari@gmail.com

Ayşegül koç, DR

CONTACT

3742752525agulkoc@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
In this study, the names of the patients hospitalized in the two wards will be sorted and numbered in alphabetical order. After the numbering process, the patients will be selected to the experimental and control group by using the "https://www.randomizer.org/" site by an independent specialist. In this study, the names of the patients hospitalized in the two wards will be sorted and numbered in alphabetical order. After the numbering process, the patients will be divided into an experimental and control group using the "https://www.randomizer.org/" site by an independent specialist.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Otolaryngology

Study Record Dates

First Submitted

September 27, 2022

First Posted

October 27, 2022

Study Start

September 1, 2022

Primary Completion

February 1, 2023

Study Completion

September 1, 2023

Last Updated

October 27, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

WE WILL PREPARE THE STUDY AS A THESIS. THEN WE WILL TURN IT INTO A PUBLICATION IN AN INTERNATIONAL MAGAZINE

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
DATA WILL BE COLLECTED FOR 1 MONTH
Access Criteria
CAN BE CONTACTED THROUGH YÖK-THESIS CENTER

Locations

TU(1)