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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05073289
Other study ID # SSoysal
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 27, 2020
Est. completion date April 2, 2021

Study information

Verified date September 2021
Source Akdeniz University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research was conducted to examine the effect of sandplay activity on anxiety and well-being levels in patients in psychiatric clinics. The research was carried out in Isparta Süleyman Demirel University Psychiatric Clinic as a single-blind randomized controlled experimental study in the pre-test, final-test order between 2020-2021. Ethical permission was obtained from the Clinical Research Ethics Committee and application permission from the institution for pre-research. 63 patients (intervention-32 and control-31) selected by block randomization method formed the universe of the study. No intervention was applied to the control group. A preliminary test and a final test were performed two days apart, one hour apart on the first and fourth days. Two sessions of sandplay activity were applied to the intervention group with a decongest of two days, and each session was pre-tested. The data was collected using "The Personal Information Form", "The Spielberger Status Anxiety" inventory, and "Well-Being Star Scale" and also data showed normal distribution. In statistical analysis, T-Test, Chi-Square Test, pearson correlation test was used dependent and independent groups. For the purpose of the research, the hypotheses of the research are as follows:: 1. Hypothesis (H1): after intervention, anxiety levels of patients who underwent sandplay activity (in a psychiatric clinic) are lower than in the control grouproup 2. Hypothesis (H1): after intervention the level of well-being of patients undergoing sand play activity (in a psychiatric clinic) is higher than that of the control group. 3. Hypothesis (H1): there is a negative correlation between the level of anxiety and the level of well-being in psychiatric clinics who sandplay activity is practiced and not practiced. This research is Turkish language.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date April 2, 2021
Est. primary completion date April 2, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria Being over 18 years old, Volunteering to participate, Not having a defect in the ability to evaluate and reason the truth, Not having hearing, understanding, and speaking problems, Not have a physical disability Exclusion Criteria from Research To be involved in another study on a similar experimental subject Being on the first day of hospitalization and on the day of discharge Removing Criteria State their willingness to leave the research voluntarily Transfer to another place and/or unscheduled early discharge

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Sandplay activity
The sandplay in psychiatric care, with a creative and fun approach, makes it easier for patients to verbally express their personal life stories and feelings in a safe environment, individually or as a group.
Other:
Routine Care
Routine care is the care given to the control group by the nurse to the patients in the psychiatry clinic.

Locations

Country Name City State
Turkey Sema Soysal Isparta Merkez

Sponsors (1)

Lead Sponsor Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary "Spielberger Status Anxiety Inventory" 4 days changes after the first interview
Primary "Well-being Star Scale" 4 days changes after the first interview
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