Child BehaviorNCT06593002
The Effect of Therapeutic Play on Children's Pain and Fear and Parents and Students' Satisfaction Levels
A study testing Therapeutic play in people with Child Behavior and Pain, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to determine the effects of playing with therapeutic toys made by nursing students on children's fear and pain levels towards treatment and the satisfaction levels of student nurses and parents. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Child Behavior, Pain, Anxiety
- 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
- 15 Apr 2022to 15 Dec 2022
- 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
- No healthy volunteers
- Child
Who may be able to join
- Having a child aged 3-6
- Having at least two days of inpatient treatment in the hospital (to gain experience with medication administration)
- Being accompanied by a parent
- Having one invasive drug treatment ordered by a doctor - Knowing and speaking Turkish
- Being willing to participate in the study
Who cannot join
- Those who are in intensive care,
- Those who have undergone surgery,
- Those who do not have a companion with their mother,
- Children with neurological and psychological disorders and parents,
- Children who only receive oral medication (as the level of pain and fear related to treatment will be low)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pre-Treatment Therapeutic Play With Nursing Students on Children's Pain and Fear and on the Satisfaction Levels of Parents and Students
This study aims to determine the effects of playing with therapeutic toys made by nursing students on children's fear and pain levels towards treatment and the satisfaction levels of student nurses and parents.
Read the detailed description
There are a limited number of studies in the literature examining the effects of therapeutic play implemented by nursing students. Although there are many studies showing that therapeutic play intervention is an effective intervention for sick children, it is seen that these studies are mostly conducted by researchers or clinical staff, and nursing students who have been in pediatric wards for a long time due to their clinical practices are far from therapeutic play practices. Therapeutic play may be a way for nursing students to initiate communication with children more easily. Therefore, there is a need for large-scale studies including nursing students. Starting from their student years, nursing students using therapeutic play as a means of communication with sick children may make them more willing to use such activities in their professional lives. In addition, determining the satisfaction levels is important for the continuation of such studies in clinical practice.
- Conditions
- Child Behavior, Pain, Anxiety, Anxiety and Fear
- Being tested
- Therapeutic play
- Keywords
- Pain, Anxiety, Children, Nursing Student, therapeutic play
- Medical subject headings
- Child Behavior, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic playBehavioural
The children in the experimental group were given a therapeutic toy designed for them by the student nurse half an hour before the treatment, the toy and game were introduced, and they were allowed to play with this toy for half an hour, accompanied by the student nurse.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Therapeutic play | Experimental | Children in the experimental group received a therapeutic video game intervention in addition to the pre-treatment routine. Receives: Behavioral: Therapeutic play |
| Control group | No intervention | Children in the control group underwent routine clinical practice. No other intervention was performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child and Parent Information Form
This form, developed by the researcher in line with the literature, was created to determine the descriptive characteristics of children and parents receiving inpatient treatment. This form was filled out by the parents of the children receiving inpatient treatment, using a face-to-face interview technique, half an hour before the treatment.
Measured: First measurement: 30 minute before treatment
Wong-Baker Pain Scale
It was developed by Wong and Baker in 1988. Patients' pain levels are evaluated by numbering their facial expressions. The numbering is as follows; "0" No pain, "1" A little pain, "2" A little more, "3" A lot more, "4" Quite a lot, "5" The most severe pain level. An increase in the score indicates that the severity of the pain also increases. This form was filled just before treatment.
Measured: First measurement: Just before treatment
Child Fear Scale
It was developed by McMurtry and his colleagues to measure the fear levels of children aged 4-10. The scale is used to measure the child's fear level. The CQ is a scale that evaluates between 0-4, consisting of five drawn facial expressions ranging from a neutral expression (0=no fear) to a frightened face (4=severe fear). This form was filled just before treatment.
Measured: First measurement: Just before treatment
Secondary outcomes (4)
Wong-Baker Pain Scale
It was developed by Wong and Baker in 1988. Patients' pain levels are evaluated by numbering their facial expressions. The numbering is as follows; "0" No pain, "1" A little pain, "2" A little more, "3" A lot more, "4" Quite a lot, "5" The most severe pain level. An increase in the score indicates that the severity of the pain also increases. This form was measured a second time immediately after treatment.
Measured: Second measurement: within five minutes after the treatment is completedAfter treatment
Child Fear Scale
It was developed by McMurtry and his colleagues to measure the fear levels of children aged 4-10. The scale is used to measure the child's fear level. The CQ is a scale that evaluates between 0-4, consisting of five drawn facial expressions ranging from a neutral expression (0=no fear) to a frightened face (4=severe fear). This form was measured a second time immediately after treatment.
Measured: Second measurement: within five minutes after the treatment is completed
Student Satisfaction Survey
The form prepared by the researchers specifically asked about the student nurses' satisfaction with making toys and playing with the sick child. It was filled out by the student nurses after the treatment.
Measured: Within five minutes after the treatment is completed
Parent Satisfaction Survey
The form prepared by the researchers specifically asked about parents' satisfaction with student nurses making toys and playing games for their children. It was filled out by parents after the treatment.
Measured: Within five minutes after the treatment is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Apr 2022
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Child BehaviorStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- Parallel groups
- Model description
- The universe of the study consisted of hospitalized children aged 3-6, their primary caregivers, and 3rd year nursing students taking the Pediatric Nursing course. Children and Parents: G\*Power 3.1.9.6. program was used to calculate the sample size of the study. According to the a priori power analysis of the study with one-way hypothesis, 0.634 effect size, 0.05 significance level, and 0.80 power; it was determined that including a total of 64 (Experiment: 32 children + parents, Control: 32 children + parents) children in the study would provide a sufficient sample size. Nursing students: No sample calculation method was used, and all students who wanted to make therapeutic toys and play games with their patients were included in the study. 141 students who wanted to participate in the study out of a total of 178 students taking the course were included in the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Küçükoğlu, Selcuk University
- Investigators
- Sibel Küçükoğlu, Study director, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593002
- Sponsor's protocol ID
- SelcukUni2525
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It can be shared after publication.
Publications
Inan G, Inal S. The Impact of 3 Different Distraction Techniques on the Pain and Anxiety Levels of Children During Venipuncture: A Clinical Trial. Clin J Pain. 2019 Feb;35(2):140-147. doi: 10.1097/AJP.0000000000000666.
PubMed 30362982Gates M, Hartling L, Shulhan-Kilroy J, MacGregor T, Guitard S, Wingert A, Featherstone R, Vandermeer B, Poonai N, Kircher J, Perry S, Graham TAD, Scott SD, Ali S. Digital Technology Distraction for Acute Pain in Children: A Meta-analysis. Pediatrics. 2020 Feb;145(2):e20191139. doi: 10.1542/peds.2019-1139. Epub 2020 Jan 22.
PubMed 31969473Li WHC, Chung JOK, Ho KY, Kwok BMC. Play interventions to reduce anxiety and negative emotions in hospitalized children. BMC Pediatr. 2016 Mar 11;16:36. doi: 10.1186/s12887-016-0570-5.
PubMed 26969158
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pre-Treatment Therapeutic Play With Nursing Students on Children's Pain and Fear and on the Satisfaction Levels of Parents and Students
- ClinicalTrials.gov ID
- NCT06593002
- Acronym / sponsor ID
- SelcukUni2525
- Conditions
- Child Behavior, Pain, Anxiety, Anxiety and Fear
- Keywords
- Pain, Anxiety, Children, Nursing Student, therapeutic play
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 19 Sep 2024 (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 aims to determine the effects of playing with therapeutic toys made by nursing students on children's fear and pain levels towards treatment and the satisfaction levels of student nurses and parents.
Detailed description
There are a limited number of studies in the literature examining the effects of therapeutic play implemented by nursing students. Although there are many studies showing that therapeutic play intervention is an effective intervention for sick children, it is seen that these studies are mostly conducted by researchers or clinical staff, and nursing students who have been in pediatric wards for a long time due to their clinical practices are far from therapeutic play practices. Therapeutic play may be a way for nursing students to initiate communication with children more easily. Therefore, there is a need for large-scale studies including nursing students. Starting from their student years, nursing students using therapeutic play as a means of communication with sick children may make them more willing to use such activities in their professional lives. In addition, determining the satisfaction levels is important for the continuation of such studies in clinical practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The universe of the study consisted of hospitalized children aged 3-6, their primary caregivers, and 3rd year nursing students taking the Pediatric Nursing course. Children and Parents: G*Power 3.1.9.6. program was used to calculate the sample size of the study. According to the a priori power analysis of the study with one-way hypothesis, 0.634 effect size, 0.05 significance level, and 0.80 power; it was determined that including a total of 64 (Experiment: 32 children + parents, Control: 32 children + parents) children in the study would provide a sufficient sample size. Nursing students: No sample calculation method was used, and all students who wanted to make therapeutic toys and play games with their patients were included in the study. 141 students who wanted to participate in the study out of a total of 178 students taking the course were included in the study.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Therapeutic play | Experimental | Behavioral: Therapeutic playChildren in the experimental group received a therapeutic video game intervention in addition to the pre-treatment routine. |
| Control group | No intervention | –Children in the control group underwent routine clinical practice. No other intervention was performed. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Having a child aged 3-6
- Having at least two days of inpatient treatment in the hospital (to gain experience with medication administration)
- Being accompanied by a parent
- Having one invasive drug treatment ordered by a doctor - Knowing and speaking Turkish
- Being willing to participate in the study
Key exclusion criteria (5 listed)
- Those who are in intensive care,
- Those who have undergone surgery,
- Those who do not have a companion with their mother,
- Children with neurological and psychological disorders and parents,
- Children who only receive oral medication (as the level of pain and fear related to treatment will be low)
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 playThe children in the experimental group were given a therapeutic toy designed for them by the student nurse half an hour before the treatment, the toy and game were introduced, and they were allowed to play with this toy for half an hour, accompanied by the student nurse. | Behavioural | Experimental: Therapeutic play |
Primary outcome
Child and Parent Information Form
Time frame: First measurement: 30 minute before treatment
This form, developed by the researcher in line with the literature, was created to determine the descriptive characteristics of children and parents receiving inpatient treatment. This form was filled out by the parents of the children receiving inpatient treatment, using a face-to-face interview technique, half an hour before the treatment.
Wong-Baker Pain Scale
Time frame: First measurement: Just before treatment
It was developed by Wong and Baker in 1988. Patients' pain levels are evaluated by numbering their facial expressions. The numbering is as follows; "0" No pain, "1" A little pain, "2" A little more, "3" A lot more, "4" Quite a lot, "5" The most severe pain level. An increase in the score indicates that the severity of the pain also increases. This form was filled just before treatment.
Child Fear Scale
Time frame: First measurement: Just before treatment
It was developed by McMurtry and his colleagues to measure the fear levels of children aged 4-10. The scale is used to measure the child's fear level. The CQ is a scale that evaluates between 0-4, consisting of five drawn facial expressions ranging from a neutral expression (0=no fear) to a frightened face (4=severe fear). This form was filled just before treatment.
4 secondary outcomes
Wong-Baker Pain Scale
Time frame: Second measurement: within five minutes after the treatment is completedAfter treatment
Child Fear Scale
Time frame: Second measurement: within five minutes after the treatment is completed
Student Satisfaction Survey
Time frame: Within five minutes after the treatment is completed
Parent Satisfaction Survey
Time frame: Within five minutes after the treatment is completed
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 19 Sep 2024.
- Results publication: PubMed 30362982Inan G, Inal S. The Impact of 3 Different Distraction Techniques on the Pain and Anxiety Levels of Children During Venipuncture: A Clinical Trial. Clin J Pain. 2019 Feb;35(2):140-147. doi: 10.1097/AJP.0000000000000666.
- Results publication: PubMed 31969473Gates M, Hartling L, Shulhan-Kilroy J, MacGregor T, Guitard S, Wingert A, Featherstone R, Vandermeer B, Poonai N, Kircher J, Perry S, Graham TAD, Scott SD, Ali S. Digital Technology Distraction for Acute Pain in Children: A Meta-analysis. Pediatrics. 2020 Feb;145(2):e20191139. doi: 10.1542/peds.2019-1139. Epub 2020 Jan 22.
- Results publication: PubMed 26969158Li WHC, Chung JOK, Ho KY, Kwok BMC. Play interventions to reduce anxiety and negative emotions in hospitalized children. BMC Pediatr. 2016 Mar 11;16:36. doi: 10.1186/s12887-016-0570-5.
- Individual participant dataSharing planned: Undecided. It can be shared after publication.
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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.
Sibel Küçükoğlu study director
Selcuk University
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 Child Behavior and Pain, run by Selcuk 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?
Child and Parent Information Form (time frame: First measurement: 30 minute before 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?
On the ClinicalTrials.gov record for NCT06593002, which also lists 3 linked publications.
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 19 Sep 2024.