- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06655961
The Effect of Gardening Activities on Anxiety and Psychosocial Symptoms of Hospitalized Children
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elif BULUT
- Phone Number: +905466681993
- Email: elf.bayrak@hotmail.com
Study Locations
-
-
-
Tokat, Turkey
- Tokat Gaziosmanpasa University
-
Contact:
- Elif BULUT
- Phone Number: +905466681993
- Email: elf.bayrak@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The age of the children is between 6-12 years old
- Hospitalization due to an acute medical diagnosis
- Hospitalization for at least 3 days
- Approval of the child's participation in the session by the responsible doctor
- The child is conscious and fully orientated
- Voluntariness of the child and parent to participate in the study
Exclusion Criteria:
- Hospitalization for more than 7 days
- No previous hospitalization experience
- High-risk drug use
- Having a chronic disease that suppresses the immune system
- Having a special condition that prevents him/her from participating in garden activities (physical, mental disability)
- Having skin conditions that prevent them from participating in garden activities
- Plant allergy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
Children in this group will receive services within the scope of the routine treatment and nursing care protocol of the clinic during hospitalisation.
No intervention will be applied to the control group of this study until the discharge process takes place.
However, on the day of discharge, the children in the control group and their parents will be informed about the garden activities by the researcher.
A single session gardening activity will be planned according to the request of the child and parent.
During this session, children will be given the opportunity to choose a plant and a pot, and then planting, watering and creating a name card will be carried out.
|
Within the scope of the clinic routine treatment and nursing protocol; the decision to hospitalize the child, orientation to the clinic, execution of hospitalization paperwork, room placement, invasive intervention and treatment procedures are carried out.
Treatment and care hours are revised according to individual order characteristics; 08.00-20.00,
08.00-16.00-00.00,
06.00-12.00-18.00-00.00
are planned considering the time order.
13.00-15.00
are the visiting hours.
The child is not allowed to leave the clinic except for any medical purpose.
No intervention will be applied to the control group of this study until the discharge process takes place.
|
|
Experimental: Intervention Group
Children in this group will have three sessions of gardening activities within the scope of the 'Gardening Activities Programme' during their hospitalisation. The sessions will take place only with the active participation of the child participant and the researcher (EB); there will be one child participant in each session. The duration of the sessions will be between 30-45 minutes. The sessions in the 'Garden Activities Programme' regarding the session planning of the activities to be carried out with children are as follows. Session 1: Pot Preparation and Plant Selection Session 2: Creating a Plant Arrangement Session 3: Care and Illustration |
When we look at the studies evaluating the effect of gardening activities on hospitalized children; it is seen that mostly children's opinions about therapeutic gardens are included and studies involving active gardening activities are limited.
Shao et al. (2020) gave hospitalized children a task about garden plants and made them full this task through active participation and mobile games.
However, it is seen that the gardening activity applied in this study was limited to a 5-minute task.
The most important difference of our study from these studies is that a standardized gardening activity program will be applied to hospitalized children during their hospitalization and the active participation of the child will be ensured.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in children's anxiety as a result of the implementation of the Garden Activity Programme
Time Frame: Will be assessed every day from the day of admission (day 1) to the 7th day of hospitalization.
|
Child Anxiety Scale-Dispositional (CAS-D): The Child Anxiety Scale-State (CAS-D) is shaped like a thermometer with a bulb at the bottom and horizontal lines with intervals going upwards.
To measure the child's state anxiety, the child is asked to tick 'what he/she is feeling at the moment'.
The score can range from 0-10.
A high scale score indicates that the child's anxiety is increasing.
|
Will be assessed every day from the day of admission (day 1) to the 7th day of hospitalization.
|
|
Changes in children's psychosocial symptoms as a result of the implementation of the Garden Activity Program
Time Frame: It will be assessed pre-intervention (1st day of hospitalization) and post-intervention (7th day of hospitalization).
|
Psychosocial Symptoms Diagnostic Scale for Hospitalized Children: The scale consists of 24 items and five sub-dimensions (anxiety, hopelessness, communication difficulties, anger and aggression, regression).
The scale has a 3-point likert-type scale, 'never: 0, sometimes: 1, often: 2'.
The score obtained from the scale varies between 0-48.
A high scale score indicates that the child hospitalized in the clinic has psychosocial problems.
|
It will be assessed pre-intervention (1st day of hospitalization) and post-intervention (7th day of hospitalization).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TOGU_HEM_EB_001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.