NCT07735351

Brief Summary

This research was planned to determine the effect of structured sandplay activities on positive and negative affect and levels of meaning in life in elderly individuals. The research will be conducted as a single-blind, randomized controlled trial with a pre-test, post-test design at the Gül Kokulu Çınarlar Vefa Konağı of the Isparta Municipality Health Affairs Directorate between July 2026 and July 2027. Prior to the research, ethical committee approval and institutional permission for implementation will be obtained. The research population consists of 400 individuals registered with the institution. The sample will consist of 60 individuals (30 in the intervention group and 30 in the control group) who meet the inclusion criteria, are selected using block randomization, and provide informed consent. The control group will receive no intervention; a pre-test will be administered on the first day, and a post-test will be administered on the day the intervention for the experimental group ends. The intervention group will participate in sandplay activities twice a week for a total of four sessions; a pre-test will be administered on the first day, and a post-test will be administered in the last session. Data collection is planned for the period between July 2026 and July 2027 using the Personal Information Form (PIF) (Appendix-1), the Positive-Negative Affect Scale (PANAS), and the Meaning in Life Scale (MLS). Data will be analyzed using the SPSS (Statistical Program for Social Sciences) statistical analysis package, and statistical significance will be accepted at p \< 0.05.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

July 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

August 17, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2027

16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

July 24, 2026

Last Update Submit

July 24, 2026

Conditions

Keywords

elderlypositive and negative emotionsmeaning in lifesandplay

Outcome Measures

Primary Outcomes (2)

  • Positive-Negative Emotion Scale (PANAS)

    In this study, this scale was used to determine positive and negative emotions. The scale was created by Watson et al. (1988) and adapted into Turkish by Gençöz (2000). This scale, which has a total of 20 items and no reverse items, has 10 items that determine positive emotions and 10 items that determine negative emotions. In the Turkish form of the scale, it is a 5-point Likert type and is rated between "very little or none (1) and very much (5)". In the original form of the scale, the Cronbach's alpha reliability coefficient was reported as 0.88 and 0.85 for positive and negative emotions, respectively. Gençöz (2000), on the other hand, calculated the Cronbach's alpha values as 0.83 and 0.86 for positive and negative emotions in his research. In the study, Cronbach's alpha value was calculated as 0.81 for positive emotion and 0.79 for negative emotion.

    At baseline and immediately after completion of the fourth intervention session.

  • Meaning in Life Scale (MLS)

    The level of meaning in life of adult individuals was measured using the Meaning in Life Scale (MLS), developed by Steger et al. (2006) and adapted into Turkish by Demirbaş (2010). The MLS consists of 10 items, comprising two sub-dimensions: the presence of meaning in life and the search for meaning in life. Participants rate the appropriateness of each item on a seven-point Likert scale ranging from definitely not true (1) to definitely true (7). Scores on the scale range from 10 to 70, with higher scores indicating a higher level of meaning in life. Demirbaş (2010) reported the internal consistency of the entire MLS as .86 in a sample of university students. The Cronbach alpha internal consistency reliability coefficient calculated in this study was .75, indicating an acceptable level of reliability (Yockey, 2011). An example item from the scale is, "I am aware of the meaning of my life."

    At baseline and immediately after completion of the fourth intervention session.

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group will participate in a total of four 60-minute Sandplay Activity sessions, twice a week.

Behavioral: Sandplay-Act. Older: Structured Sandplay Activity for Older Individuals

Control Group

OTHER
Other: Control

Interventions

Sandplay-Act Older (Structured Sandplay Activity for Older Individuals) is a structured sandplay activity developed to support older individuals in expressing their emotions, thoughts, and life experiences symbolically. The intervention consists of structured sessions where participants create scenes in a sand tray using miniature figures and make sense of their life experiences through these scenes. The program will be conducted twice a week for a total of four sessions. Each session will last approximately 60 minutes.

Intervention Group
ControlOTHER

Participants in the control group will not participate in structured sand play activities during the study period. Participants will continue with the institution's routine care and social activities; however, no psychosocial interventions will be applied within the scope of the study.

Control Group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Voluntary participation in the study
  • No specific condition that would cause learning difficulties (auditory or visual perception disorders, etc.)
  • Being between 65-80 years of age
  • No acute psychiatric disorder or severe cognitive impairment

You may not qualify if:

  • Having a mental or physical disability that prevents communication and attendance at sessions (inability to speak, diagnosis of severe dementia, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suleyman Demirel University

Isparta, Turkey (Türkiye)

Location

Study Officials

  • sema soysal

    Suleyman Demirel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 24, 2026

First Posted

July 30, 2026

Study Start (Estimated)

August 17, 2026

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations