Child BehaviorNCT06415188
The Effect of Therapeutic Play on Pain, Fear, Anxiety and Physiological Parameters and Parents' Satisfaction
A study testing Video game with headset in people with Child Behavior and Pain, Acute, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effect of the therapeutic game applied before treatment on pain, fear, anxiety and physiological parameters and the satisfaction of the parents was investigated. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Child Behavior, Pain, Acute, Anxiety and Fear
- What is being tested?
- Video game with headset
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2023to 10 May 2024
- 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
- Being in the 3-6 age group,
- At least one day of inpatient treatment in the pediatric clinics of Selçuk Medical Faculty Hospital
- At least one invasive intervention in the treatment plan
- To be able to understand and speak Turkish
- Staying in a room with at least two beds
- Staying with their child as a constant companion
Show all 10Show fewer
- To be able to understand and speak Turkish
- Accepting to participate in the study
- The exclusion criteria:
- Not staying with your child all the time
Who cannot join
- Having a neurological disorder
- Not having a parent as a companion
- Receiving oral treatment only
- Hearing and vision problems
- Single bed capacity room or isolated room
- For the Parent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Therapeutic Play on Pre-Treatment Pain, Fear, Anxiety and Physiological Parameters and Parents' Satisfaction
In this study, the effect of the therapeutic game applied before treatment on pain, fear, anxiety and physiological parameters and the satisfaction of the parents was investigated.
Read the detailed description
Therapeutic play is defined as activities structured in accordance with children's age and development, or as a set of interventions to improve the well-being of children in the hospital environment. This method reduces the stress of illness or hospitalization, uses play as a means of self-expression and supports the development of positive coping mechanisms in pediatric patients. In the literature, it is seen that therapeutic play methods such as listening to music, drawing, reading stories, puppets, dolls, virtual reality tools, cartoon applications, watching videos and playing video games are used to reduce the child's pain and anxiety about invasive procedures. Studies conducted to reduce the interactions between children in the same environment during their treatment and care are quite limited. No study has been found to examine the effect of methods that jointly block/reduce vision and hearing during treatment and care on anxiety, fear and pain in children treated together in pediatric clinics.
- Conditions
- Child Behavior, Pain, Acute, Anxiety and Fear
- Being tested
- Video game with headset
- Keywords
- Pain, anxiety, children, nursing, therapeutic play
- Medical subject headings
- Child Behavior, Acute Pain, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video game with headsetBehavioural
Half an hour before the first treatment in the morning, the screens around the patients' beds were closed by the researcher. The child was asked to choose one of the introduced games and the game he/she chose from the tablet was turned on. Children were asked to wear headphones for sound isolation and the sound was adjusted at the appropriate decibel setting. Half an hour before the treatment, children were allowed to play the video game until the treatment without any different warning. Physiologic Parameter Assessment Form, Child Anxiety and Fear Scale, Child Pain Scale were filled by the researcher 1 minute before and 1 minute after the procedure. Finally, Parental Satisfaction Scale was completed at the end of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic play group | Experimental | Children in the experimental group received a therapeutic video game intervention in addition to the pre-treatment routine. Receives: Behavioral: Video game with headset |
| 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.
Descriptive Characteristics Information Form
A descriptive characteristics information form for parents and children was prepared by the researchers in line with the literature and the data of both the experimental and control groups were collected before the intervention.
Measured: First measurement: 30 minute before treatment
Physiological Parameter Monitoring Form
The descriptive characteristics form was based on a literature review by the investigator. Heart rate (min), oxygen saturation (SpO2%), blood pressure (mmHg) and respiratory rate (min) were measured 1 minute before treatment administration.
Measured: First measurement: 1 minute before treatment
Children's State Anxiety and Children's Fear Scale
Children's State Anxiety and Children's Fear Scale was developed by McMurtry et al. in 2011. The scale was designed to measure the fear levels of children aged 4-10 years. The scale was translated into Turkish by Gerçeker et al. in 2018 and the validity-reliability coefficient was found to be 0.89. The scale score is formed by scoring five drawn facial expressions (0=no fear to 4=severe fear) shown visually to the child. Anxiety and fear scores of the child were scored one minute before the treatment.
Measured: First measurement: 1 minute before treatment
Visual Analog Scale
Visual Analog Scale (VAS) was developed by Wong and Baker in 1988. Patients' pain levels are evaluated by scoring with facial expressions. It is used in children who have the ability to communicate and are conscious. The scale has 6 faces that are scored between 0 and 5. In scoring, the child chooses the face that best expresses him/her and "0" indicates no pain, "1" indicates a little pain, "2" indicates a little more pain, "3" indicates more pain, "4" indicates quite a lot of pain and "5" indicates the most severe pain level. One minute before the treatment, the child's pain is scored by VAS.
Measured: First measurement: 1 minute before treatment
PedsQL Health Care Satisfaction Scale
The PedsQL Health Care Satisfaction Scale was developed by J.W. Varni in 1999. Turkish adaptation of the scale was conducted by Ulus and Kublay in 2012. The scale consists of 25 items with 6 subheadings: emotional support, information, general satisfaction, communication, family involvement and technical skills. The scale is on a five-point scale and each item is rated on a scale of 0 to 4 and is evaluated as "Never satisfied (0)", "Sometimes satisfied (1)", "Most of the time satisfied (2)", "Almost always satisfied (3)" and "Always satisfied (4)". A high score indicates an increase in parental satisfaction.
Measured: First measurement: After treatment
Secondary outcomes (3)
Physiological Parameter Monitoring Form
Heart rate (min), oxygen saturation (SpO2%), blood pressure (mmHg) and respiratory rate (min) were measured one minute after treatment administration.
Measured: Second measurement: 1 minute after treatment
Children's State Anxiety and Children's Fear Scale
1 minute after the treatment, the child's anxiety and fear score was scored again.
Measured: Second measurement: 1 minute after treatment
Visual Analog Scale
One minute after the treatment, the child's pain score was scored again
Measured: Second measurement: 1 minute after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start15 May 2023
- Primary completion15 Apr 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- This study was conducted on children aged 3-6 years. The study was completed with a total of 40 children and parent pairs in the experimental and control groups. Simple randomization method was used in the study. The randomization table for which group the children would be in was made by an independent statistician. Letters A and B were used to represent the experimental and control groups. Which letter represented which group was determined by lottery. While therapeutic play intervention was applied in the experimental group, routine intervention was applied in the control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 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 Kucukoglu, Prof, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415188
- Sponsor's protocol ID
- SelcukUni2544
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared after the article is published.
Publications
Bergomi P, Scudeller L, Pintaldi S, Dal Molin A. Efficacy of Non-pharmacological Methods of Pain Management in Children Undergoing Venipuncture in a Pediatric Outpatient Clinic: A Randomized Controlled Trial of Audiovisual Distraction and External Cold and Vibration. J Pediatr Nurs. 2018 Sep-Oct;42:e66-e72. doi: 10.1016/j.pedn.2018.04.011. Epub 2018 May 1.
PubMed 29728296Silva SGTD, Santos MA, Floriano CMF, Damiao EBC, Campos FV, Rossato LM. Influence of Therapeutic Play on the anxiety of hospitalized school-age children: Clinical trial. Rev Bras Enferm. 2017 Nov-Dec;70(6):1244-1249. doi: 10.1590/0034-7167-2016-0353. English, Portuguese.
PubMed 29160486Roberts JG, Prys-Roberts C, Foex P, Clarke TN, Bennett M. Proceedings: A comparison of the effects of practolol and propranolol on the response to haemorrhage in anaesthetized dogs after myocardial infarction. Br J Anaesth. 1973 Dec;45(12):1230. doi: 10.1093/bja/45.12.1230. No abstract available.
PubMed 4787017Kose S, Arikan D. The Effects of Cartoon Assisted Endoscopy Preparation Package on Children's Fear and Anxiety Levels and Parental Satisfaction in Turkey. J Pediatr Nurs. 2020 Jul-Aug;53:e72-e79. doi: 10.1016/j.pedn.2020.02.010. Epub 2020 Mar 13.
PubMed 32173165Inan 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 30362982Masmoudi A, el-Fetouaki J, Weltin D, Belhadj O, Mandel P. Association of mitochondrial ADP-ribosyl transferase activity with the DNA-protein complex. Biochem Mol Biol Int. 1993 Jan;29(1):77-83.
PubMed 8387848Burns-Nader S, Joe L, Pinion K. Computer tablet distraction reduces pain and anxiety in pediatric burn patients undergoing hydrotherapy: A randomized trial. Burns. 2017 Sep;43(6):1203-1211. doi: 10.1016/j.burns.2017.02.015. Epub 2017 Mar 18.
PubMed 28318748Kilincat B, Kucukoglu S. The effect of pre-treatment therapeutic play on pain, fear, physiological parameters, and parental satisfaction in preschool children: A randomized controlled trial. J Pediatr Nurs. 2026 Jul 20;90:607-617. doi: 10.1016/j.pedn.2026.07.026. Online ahead of print.
PubMed 42475850
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Play on Pre-Treatment Pain, Fear, Anxiety and Physiological Parameters and Parents' Satisfaction
- ClinicalTrials.gov ID
- NCT06415188
- Acronym / sponsor ID
- SelcukUni2544
- Conditions
- Child Behavior, Pain, Acute, Anxiety and Fear
- Keywords
- Pain, anxiety, children, nursing, therapeutic play
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 16 May 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.
In this study, the effect of the therapeutic game applied before treatment on pain, fear, anxiety and physiological parameters and the satisfaction of the parents was investigated.
Detailed description
Therapeutic play is defined as activities structured in accordance with children's age and development, or as a set of interventions to improve the well-being of children in the hospital environment. This method reduces the stress of illness or hospitalization, uses play as a means of self-expression and supports the development of positive coping mechanisms in pediatric patients. In the literature, it is seen that therapeutic play methods such as listening to music, drawing, reading stories, puppets, dolls, virtual reality tools, cartoon applications, watching videos and playing video games are used to reduce the child's pain and anxiety about invasive procedures. Studies conducted to reduce the interactions between children in the same environment during their treatment and care are quite limited. No study has been found to examine the effect of methods that jointly block/reduce vision and hearing during treatment and care on anxiety, fear and pain in children treated together in pediatric clinics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study was conducted on children aged 3-6 years. The study was completed with a total of 40 children and parent pairs in the experimental and control groups. Simple randomization method was used in the study. The randomization table for which group the children would be in was made by an independent statistician. Letters A and B were used to represent the experimental and control groups. Which letter represented which group was determined by lottery. While therapeutic play intervention was applied in the experimental group, routine intervention was applied in the control group.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic play group | Experimental | Behavioral: Video game with headsetChildren 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 (10 listed)
- Being in the 3-6 age group,
- At least one day of inpatient treatment in the pediatric clinics of Selçuk Medical Faculty Hospital
- At least one invasive intervention in the treatment plan
- To be able to understand and speak Turkish
- Staying in a room with at least two beds
Key exclusion criteria (6 listed)
- Having a neurological disorder
- Not having a parent as a companion
- Receiving oral treatment only
- Hearing and vision problems
- Single bed capacity room or isolated room
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 |
|---|---|---|
| Video game with headsetHalf an hour before the first treatment in the morning, the screens around the patients' beds were closed by the researcher. The child was asked to choose one of the introduced games and the game he/she chose from the tablet was turned on. Children were asked to wear headphones for sound isolation and the sound was adjusted at the appropriate decibel setting. Half an hour before the treatment, children were allowed to play the video game until the treatment without any different warning. Physiologic Parameter Assessment Form, Child Anxiety and Fear Scale, Child Pain Scale were filled by the researcher 1 minute before and 1 minute after the procedure. Finally, Parental Satisfaction Scale was completed at the end of the intervention. | Behavioural | Therapeutic play group |
Primary outcome
Descriptive Characteristics Information Form
Time frame: First measurement: 30 minute before treatment
A descriptive characteristics information form for parents and children was prepared by the researchers in line with the literature and the data of both the experimental and control groups were collected before the intervention.
Physiological Parameter Monitoring Form
Time frame: First measurement: 1 minute before treatment
The descriptive characteristics form was based on a literature review by the investigator. Heart rate (min), oxygen saturation (SpO2%), blood pressure (mmHg) and respiratory rate (min) were measured 1 minute before treatment administration.
Children's State Anxiety and Children's Fear Scale
Time frame: First measurement: 1 minute before treatment
Children's State Anxiety and Children's Fear Scale was developed by McMurtry et al. in 2011. The scale was designed to measure the fear levels of children aged 4-10 years. The scale was translated into Turkish by Gerçeker et al. in 2018 and the validity-reliability coefficient was found to be 0.89. The scale score is formed by scoring five drawn facial expressions (0=no fear to 4=severe fear) shown visually to the child. Anxiety and fear scores of the child were scored one minute before the treatment.
Visual Analog Scale
Time frame: First measurement: 1 minute before treatment
Visual Analog Scale (VAS) was developed by Wong and Baker in 1988. Patients' pain levels are evaluated by scoring with facial expressions. It is used in children who have the ability to communicate and are conscious. The scale has 6 faces that are scored between 0 and 5. In scoring, the child chooses the face that best expresses him/her and "0" indicates no pain, "1" indicates a little pain, "2" indicates a little more pain, "3" indicates more pain, "4" indicates quite a lot of pain and "5" indicates the most severe pain level. One minute before the treatment, the child's pain is scored by VAS.
PedsQL Health Care Satisfaction Scale
Time frame: First measurement: After treatment
The PedsQL Health Care Satisfaction Scale was developed by J.W. Varni in 1999. Turkish adaptation of the scale was conducted by Ulus and Kublay in 2012. The scale consists of 25 items with 6 subheadings: emotional support, information, general satisfaction, communication, family involvement and technical skills. The scale is on a five-point scale and each item is rated on a scale of 0 to 4 and is evaluated as "Never satisfied (0)", "Sometimes satisfied (1)", "Most of the time satisfied (2)", "Almost always satisfied (3)" and "Always satisfied (4)". A high score indicates an increase in parental satisfaction.
3 secondary outcomes
Physiological Parameter Monitoring Form
Time frame: Second measurement: 1 minute after treatment
Children's State Anxiety and Children's Fear Scale
Time frame: Second measurement: 1 minute after treatment
Visual Analog Scale
Time frame: Second measurement: 1 minute after treatment
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 16 May 2024.
- Background: PubMed 29728296Bergomi P, Scudeller L, Pintaldi S, Dal Molin A. Efficacy of Non-pharmacological Methods of Pain Management in Children Undergoing Venipuncture in a Pediatric Outpatient Clinic: A Randomized Controlled Trial of Audiovisual Distraction and External Cold and Vibration. J Pediatr Nurs. 2018 Sep-Oct;42:e66-e72. doi: 10.1016/j.pedn.2018.04.011. Epub 2018 May 1.
- Background: PubMed 29160486Silva SGTD, Santos MA, Floriano CMF, Damiao EBC, Campos FV, Rossato LM. Influence of Therapeutic Play on the anxiety of hospitalized school-age children: Clinical trial. Rev Bras Enferm. 2017 Nov-Dec;70(6):1244-1249. doi: 10.1590/0034-7167-2016-0353. English, Portuguese.
- Background: PubMed 4787017Roberts JG, Prys-Roberts C, Foex P, Clarke TN, Bennett M. Proceedings: A comparison of the effects of practolol and propranolol on the response to haemorrhage in anaesthetized dogs after myocardial infarction. Br J Anaesth. 1973 Dec;45(12):1230. doi: 10.1093/bja/45.12.1230. No abstract available.
- Background: PubMed 32173165Kose S, Arikan D. The Effects of Cartoon Assisted Endoscopy Preparation Package on Children's Fear and Anxiety Levels and Parental Satisfaction in Turkey. J Pediatr Nurs. 2020 Jul-Aug;53:e72-e79. doi: 10.1016/j.pedn.2020.02.010. Epub 2020 Mar 13.
- Background: 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.
- Background: PubMed 8387848Masmoudi A, el-Fetouaki J, Weltin D, Belhadj O, Mandel P. Association of mitochondrial ADP-ribosyl transferase activity with the DNA-protein complex. Biochem Mol Biol Int. 1993 Jan;29(1):77-83.
- Background: PubMed 28318748Burns-Nader S, Joe L, Pinion K. Computer tablet distraction reduces pain and anxiety in pediatric burn patients undergoing hydrotherapy: A randomized trial. Burns. 2017 Sep;43(6):1203-1211. doi: 10.1016/j.burns.2017.02.015. Epub 2017 Mar 18.
- Derived from this study: PubMed 42475850Kilincat B, Kucukoglu S. The effect of pre-treatment therapeutic play on pain, fear, physiological parameters, and parental satisfaction in preschool children: A randomized controlled trial. J Pediatr Nurs. 2026 Jul 20;90:607-617. doi: 10.1016/j.pedn.2026.07.026. Online ahead of print.
- Individual participant dataSharing planned: No. It will be shared after the article is published.
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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 Kucukoglu, Prof principal investigator
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 Video game with headset in people with Child Behavior and Pain, Acute, 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 10 inclusion and 6 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 16 May 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?
Descriptive Characteristics Information Form (time frame: First measurement: 30 minute before treatment). The study lists 5 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 NCT06415188, which also lists 8 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 16 May 2024.