HydrotherapyNCT05808738
The Effect of Therapeutic Play on Pain, Fear and Emotional Indicator
A study testing therapeutic play in people with Hydrotherapy, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to determine the effect of therapeutic play and preparation for hydrotherapy treatment on pain, fear and emotional indicator levels in children with burn injuries. It is an experimental randomized controlled study. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydrotherapy
- What is being tested?
- therapeutic play
- 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
- 1 Jan 2024to 1 Jan 2025
- 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The child is between 3-6 years old
- The child is receiving the first hydrotherapy treatment in the clinic.
- Presence of second and/or third degree superficial and/or deep burns
- Volunteering of the child and family to participate in the research
- The child was given analgesics half an hour before the procedure.
- No simultaneous debridement during hydrotherapy
- Burn width between 20%-70%
Who cannot join
- The child is younger than 3 years old, over 6 years old
- Presence of any other chronic disease other than burns
- The child is receiving mechanical ventilator support.
- Having a trecheostomy done to the child
- The child has been given sedative medication in the last 8 hours.
- Having a companion other than mother or father
- Hydrotherapy treatment takes less than 30 minutes, more than 45 minutes
- The child does not want to play
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Eskisehir Osmangazi University
Eskişehir, Odunpazarı, 26000
Elif Nilay ak, 05536079124, kzlynilay@hotmail.com
About this study
Official title: The Effect of Therapeutic Gaming Used in Preparation for Hydrothera-py Treatment on Children's Pain, Fear and Emotional Indicators: A Ran-domized, Controlled, Treatment Study
This study was planned to determine the effect of therapeutic play and preparation for hydrotherapy treatment on pain, fear and emotional indicator levels in children with burn injuries.
It is an experimental randomized controlled study. The population of the research will be children between the ages of 3-6 who are hospitalized in the Pediatric Burn Intensive Care Unit. As a result of the power analysis using the G*Power 3.0.10 program, at least 52 children in total (control group 26, therapeutic play group 26) with 50% power, 0.05 alpha margin of error, 0.80 beta margin of error and 20% effect size. was determined to be included in the study. However, considering the case losses, the number of children to be included in the study was determined as 64 by increasing the sample size by 20%. The data will be collected between the dates to be determined by the researcher after obtaining the ethics committee approval and written permission from the institution where the research will be conducted. Introductory information form, FLACC Pain Scale, Child Fear Scale and Child Emotional Indicators Scale will be used to collect research data.
The research will be conducted with the children of parents who agreed to participate in the study. There are two groups, the control group and the experimental group. While the routine practice of the clinic will be applied to the control group, creative therapeutic games will be played to the experimental group together with the routine practice. Children will be stratified according to their pain scores, fear scores and burn depth (degree) and will be assigned to an equal number of children in each group using the blocking method. Before the procedure, the introductory information form will be filled in by the researcher in line with the patient file and parent information. After parents are informed about which group the child is in, their written consent will be obtained.
- Conditions
- Hydrotherapy
- Being tested
- therapeutic play
- Keywords
- hyrotherapy, therapeutic game, child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic playBehavioural
therapeutic game will be played to prepare children for hydrotherapy treatment
| Study group | Role | What they receive |
|---|---|---|
| therapeutic game group | Active comparator | therapeutic play will be played 10 minutes before the hydrotherapy treatment. Receives: Behavioral: therapeutic play |
| control group | No intervention | No intervention was given to the children prior to hydrotherapy treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the pain level of the children will be evaluated by applying the FLACC pain scale to the children by the researcher.
therapeutic game was played for children 10 minutes before hydrotherapy treatment
Measured: Pain assessment will be done 30 minutes before hydrotherapy treatment.
The change in the pain level of the children will be evaluated by applying the FLACC pain scale to the children by the researcher.
therapeutic game was played for children 10 minutes before hydrotherapy treatment
Measured: Pain assessment will be done 10 minutes after hydrotherapy treatment.
The change in the pain level of the children will be evaluated by applying the FLACC pain scale to the children by the researcher.
therapeutic game was played for children 10 minutes before hydrotherapy treatment
Measured: Pain assessment will be done 30 minutes after hydrotherapy treatment.
Secondary outcomes (3)
The change in the children's fear level will be evaluated by applying the Child Fear Scale to the children by the researcher.
therapeutic game was played for children 10 minutes before hydrotherapy treatment
Measured: Fear assessment will be done 30 minutes before hydrotherapy treatment.
The change in the children's fear level will be evaluated by applying the Child Fear Scale to the children by the researcher.
therapeutic game was played for children 10 minutes before hydrotherapy treatment
Measured: Fear assessment will be done 10 minutes after hydrotherapy treatment.
The change in the children's fear level will be evaluated by applying the Child Fear Scale to the children by the researcher.
therapeutic game was played for children 10 minutes before hydrotherapy treatment
Measured: Fear assessment will be done 30 minutes after hydrotherapy treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrotherapyStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Nilay Kizilay, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808738
- Sponsor's protocol ID
- DOKTORA TEZ
- Status last verified
- Dec 2023
- First submitted
- 8 Jan 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Gaming Used in Preparation for Hydrothera-py Treatment on Children's Pain, Fear and Emotional Indicators: A Ran-domized, Controlled, Treatment Study
- ClinicalTrials.gov ID
- NCT05808738
- Acronym / sponsor ID
- DOKTORA TEZ
- Conditions
- Hydrotherapy
- Keywords
- hyrotherapy, therapeutic game, child
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 11 Apr 2023 (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 study was planned to determine the effect of therapeutic play and preparation for hydrotherapy treatment on pain, fear and emotional indicator levels in children with burn injuries.
It is an experimental randomized controlled study. The population of the research will be children between the ages of 3-6 who are hospitalized in the Pediatric Burn Intensive Care Unit. As a result of the power analysis using the G*Power 3.0.10 program, at least 52 children in total (control group 26, therapeutic play group 26) with 50% power, 0.05 alpha margin of error, 0.80 beta margin of error and 20% effect size. was determined to be included in the study. However, considering the case losses, the number of children to be included in the study was determined as 64 by increasing the sample size by 20%. The data will be collected between the dates to be determined by the researcher after obtaining the ethics committee approval and written permission from the institution where the research will be conducted. Introductory information form, FLACC Pain Scale, Child Fear Scale and Child Emotional Indicators Scale will be used to collect research data.
The research will be conducted with the children of parents who agreed to participate in the study. There are two groups, the control group and the experimental group. While the routine practice of the clinic will be applied to the control group, creative therapeutic games will be played to the experimental group together with the routine practice. Children will be stratified according to their pain scores, fear scores and burn depth (degree) and will be assigned to an equal number of children in each group using the blocking method. Before the procedure, the introductory information form will be filled in by the researcher in line with the patient file and parent information. After parents are informed about which group the child is in, their written consent will be obtained.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| therapeutic game group | Active comparator | Behavioral: therapeutic playtherapeutic play will be played 10 minutes before the hydrotherapy treatment. |
| control group | No intervention | –No intervention was given to the children prior to hydrotherapy treatment. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- The child is between 3-6 years old
- The child is receiving the first hydrotherapy treatment in the clinic.
- Presence of second and/or third degree superficial and/or deep burns
- Volunteering of the child and family to participate in the research
- The child was given analgesics half an hour before the procedure.
Key exclusion criteria (8 listed)
- The child is younger than 3 years old, over 6 years old
- Presence of any other chronic disease other than burns
- The child is receiving mechanical ventilator support.
- Having a trecheostomy done to the child
- The child has been given sedative medication in the last 8 hours.
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 |
|---|---|---|
| therapeutic playtherapeutic game will be played to prepare children for hydrotherapy treatment | Behavioural | therapeutic game group |
Primary outcome
The change in the pain level of the children will be evaluated by applying the FLACC pain scale to the children by the researcher.
Time frame: Pain assessment will be done 30 minutes before hydrotherapy treatment.
therapeutic game was played for children 10 minutes before hydrotherapy treatment
The change in the pain level of the children will be evaluated by applying the FLACC pain scale to the children by the researcher.
Time frame: Pain assessment will be done 10 minutes after hydrotherapy treatment.
therapeutic game was played for children 10 minutes before hydrotherapy treatment
The change in the pain level of the children will be evaluated by applying the FLACC pain scale to the children by the researcher.
Time frame: Pain assessment will be done 30 minutes after hydrotherapy treatment.
therapeutic game was played for children 10 minutes before hydrotherapy treatment
3 secondary outcomes
The change in the children's fear level will be evaluated by applying the Child Fear Scale to the children by the researcher.
Time frame: Fear assessment will be done 30 minutes before hydrotherapy treatment.
The change in the children's fear level will be evaluated by applying the Child Fear Scale to the children by the researcher.
Time frame: Fear assessment will be done 10 minutes after hydrotherapy treatment.
The change in the children's fear level will be evaluated by applying the Child Fear Scale to the children by the researcher.
Time frame: Fear assessment will be done 30 minutes after hydrotherapy treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic play in people with Hydrotherapy, run by Eskisehir Osmangazi 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?
The sponsor lists 7 inclusion and 8 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 12 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elif nilay Ak (05536079124, kzlynilay@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the pain level of the children will be evaluated by applying the FLACC pain scale to the children by the researcher. (time frame: Pain assessment will be done 30 minutes before hydrotherapy treatment.). The study lists 3 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 12 Dec 2023.