NCT05073289

Brief 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. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 11, 2021

Completed
Last Updated

October 11, 2021

Status Verified

September 1, 2021

Enrollment Period

1.1 years

First QC Date

September 29, 2021

Last Update Submit

September 29, 2021

Conditions

Keywords

anxiety, well-being, sandplay, psychiatric nursing, psychiatric care

Outcome Measures

Primary Outcomes (2)

  • "Spielberger Status Anxiety Inventory"

    4 days changes after the first interview

  • "Well-being Star Scale"

    4 days changes after the first interview

Study Arms (2)

SAPC

EXPERIMENTAL

SAPC is a acronmy that defines Sandplay activity in psychiatry clinic

Behavioral: Sandplay activity

Control Group

ACTIVE COMPARATOR
Other: Routine Care

Interventions

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.

SAPC

Routine care is the care given to the control group by the nurse to the patients in the psychiatry clinic.

Control Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Removing Criteria State their willingness to leave the research voluntarily Transfer to another place and/or unscheduled early discharge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sema Soysal

Isparta, Merkez, 320200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients with a diagnosis of mental disorder in the psychiatry clinic
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Randomized Control Experimental Research
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 11, 2021

Study Start

February 27, 2020

Primary Completion

April 2, 2021

Study Completion

April 2, 2021

Last Updated

October 11, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations