Sandplay TherapyNCT05073289
Sandplay Activity in Psychiatry Clinic (SAPC)
A study testing Sandplay activity and Routine Care in people with Sandplay Therapy and Anxiety, run by Akdeniz University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sandplay Therapy, Anxiety
- What is being tested?
- Sandplay activity and Routine Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Feb 2020to 2 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EXAMINATION OF THE EFFECT OF" SANDPLAY ACTIVITY " ON ANXIETY AND WELL-BEING IN PATIENTS IN A PSYCHIATRIC CLINIC
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.
Read more
For the purpose of the research, the hypotheses of the research are as follows::
- Hypothesis (H1): after intervention, anxiety levels of patients who underwent sandplay activity (in a psychiatric clinic) are lower than in the control grouproup
- 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.
- 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.
- Conditions
- Sandplay Therapy, Anxiety
- Being tested
- Sandplay activity, Routine Care
- Keywords
- anxiety, well-being, sandplay, psychiatric nursing, psychiatric care
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sandplay activityBehavioural
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.
Routine CareOther
Routine care is the care given to the control group by the nurse to the patients in the psychiatry clinic.
| Study group | Role | What they receive |
|---|---|---|
| SAPC | Experimental | SAPC is a acronmy that defines Sandplay activity in psychiatry clinic Receives: Behavioral: Sandplay activity |
| Control Group | Active comparator | Not described Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Spielberger Status Anxiety Inventory"
Measured: 4 days changes after the first interview
"Well-being Star Scale"
Measured: 4 days changes after the first interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start27 Feb 2020
- Primary completion2 Apr 2021
- Study completion2 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sandplay TherapyStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomized Control Experimental Research
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sema Soysal, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073289
- Sponsor's protocol ID
- SSoysal
- Status last verified
- Sep 2021
- First submitted
- 29 Sep 2021
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXAMINATION OF THE EFFECT OF" SANDPLAY ACTIVITY " ON ANXIETY AND WELL-BEING IN PATIENTS IN A PSYCHIATRIC CLINIC
- ClinicalTrials.gov ID
- NCT05073289
- Acronym / sponsor ID
- SSoysal
- Conditions
- Sandplay Therapy, Anxiety
- Keywords
- anxiety, well-being, sandplay, psychiatric nursing, psychiatric care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 2 Apr 2021 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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::
- Hypothesis (H1): after intervention, anxiety levels of patients who underwent sandplay activity (in a psychiatric clinic) are lower than in the control grouproup
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Control Experimental Research
| Arm | Type | Receives |
|---|---|---|
| SAPC | Experimental | Behavioral: Sandplay activitySAPC is a acronmy that defines Sandplay activity in psychiatry clinic |
| Control Group | Active comparator | Other: Routine Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sandplay activityThe 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. | Behavioural | SAPC |
| Routine CareRoutine care is the care given to the control group by the nurse to the patients in the psychiatry clinic. | Other | Control Group |
Primary outcome
"Spielberger Status Anxiety Inventory"
Time frame: 4 days changes after the first interview
"Well-being Star Scale"
Time frame: 4 days changes after the first interview
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Sandplay Therapy
Not yet recruiting
Sandplay-Act. Older: Structured Sandplay Activity for Older Individuals
Healthy Aging, Elderly (People Aged 65 or More)
Not yet recruitingObservational study
Chinese University Students' Death Attitudes and Their Initial Sandplay Characteristics
Death Attitude (Implicit/Explicit), Sandplay Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sandplay activity and Routine Care in people with Sandplay Therapy and Anxiety, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Spielberger Status Anxiety Inventory" (time frame: 4 days changes after the first interview). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.