Preoperative CareNCT05540041
Reducing Anxiety of Children and Their Parents in the Pre-Operative Process With Therapeutic Play
A study testing Bubble breathing play therapy group and Tell-show-do play therapy group in people with Preoperative Care and Child, run by Isparta University of Applied Sciences at 1 site in Turkey (Türkiye).
Trial summary
It is emphasized in studies that child and parent anxiety that arises in pediatric surgery should be prevented or reduced. According to previous studies, one way to reduce child and parent anxiety in the preoperative period is therapeutic play interventions. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Preoperative Care, Child, Parents
- What is being tested?
- Bubble breathing play therapy group and Tell-show-do play therapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Oct 2022to 24 Mar 2026
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being a child between the ages of 5-12 for which a surgical operation is planned
- Being the parent of a child between the ages of 5 and 12 whose surgical operation is planned
- Not having vision, hearing or speech problems
- Not have a mental or neurological disability
- Not being diagnosed with an anxiety disorder
- Children and parents who can speak and understand Turkish will be included in the study
Who cannot join
- Change in surgical operation date
- Using another distraction technique
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Bubble Breathing Play Therapy and Tell-show-do Play Therapy in the Preoperative Anxiety Children and Their Parent
It is emphasized in studies that child and parent anxiety that arises in pediatric surgery should be prevented or reduced. According to previous studies, one way to reduce child and parent anxiety in the preoperative period is therapeutic play interventions. This study was planned to compare the effectiveness of two different therapeutic play interventions (bubble breathing play therapy and tell-show-do play therapy) in reducing preoperative anxiety of children and parents who are scheduled for elective surgery.
Read the detailed description
Aim: This study was planned to comparison of the effectiveness of two different therapeutic play interventions (bubble breathing play therapy and tell-show-do play therapy) in reducing preoperative anxiety of children and parents who are scheduled for elective surgery.
Method: This study was planned as a randomized controlled trial. The sample of the study will consist of 105 children aged 5-12, who will be operated on at Akdeniz University Hospital, and their parents. Randomization result; It was planned to include a total of 105 children and their parents in 3 groups: bubble breathing play therapy group (intervention group 1)= 35, tell-show-do play therapy group (intervention group 2)= 35 , and control group= 35 children and parents.
Child and parent information form will be used to collect data, Modified Yale Preoperative Anxiety Scale will be used to collect data in child sample, and Spielberger State Anxiety Scale will be used to collect data in parent sample.
Intervention and Data Collection: Randomization will be performed after the purpose of the study is explained to the child and parent who agreed to participate in the study and after obtaining consent. Immediately after the pretest (first measurement) is given to the children assigned to intervention group 1 and their parents, attempts to bubble breathing play therapy will be applied for 5-10 minutes. If they wish, the child and parents will be told that they can continue to play with the bubble toys until premedication. Children assigned to intervention group 2 and their parents will be tell-show-do play therapy for 10-15 minutes immediately after the pre-test (first measurement) is done. Participants randomized to the control group will be given routine standard nursing care. The second measurement will be just before premedication (post test). Thus, the effectiveness of the initiatives and their comparison with each other will be evaluated.
The data of the research will be analyzed using the Statistical Package of Social Science (SPSS) 23.0 software package program. The process of evaluating the data will be carried out with the support of a statistician.
- Conditions
- Preoperative Care, Child, Parents, Anxiety
- Being tested
- Bubble breathing play therapy group, Tell-show-do play therapy group, No intervention
- Keywords
- Preoperative Care, Child, Parents, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bubble breathing play therapy groupOther
The efficacy of bubble breathing play therapy in the preoperative anxiety children and their parent.
Tell-show-do play therapy groupOther
The efficacy of tell-show-do play therapy in the preoperative anxiety children and their parent.
No interventionOther
Routine nursing care
| Study group | Role | What they receive |
|---|---|---|
| Bubble breathing play therapy | Experimental | Children in intervention group 2 will be given a bubble breathing play therapy intervention. With this intervention, it is aimed to teach the child and parent to breathe correctly and deeply, to relax them, to reduce their anxiety and fears, to relax, to direct their attention to something other than pain. In the intervention pediatric surgery service, investigative coaching will be applied 30 minutes before premedication. The procedure time is planned to be at least 5-10 minutes. The intervention will be implemented with a ready-made foam bubble toy. The toy will be provided by the researcher and given to the children as a gift. Receives: Other: Bubble breathing play therapy group |
| Tell-show-do play therapy | Experimental | Tell-show-do play therapy initiative will be applied to children included in intervention group 1. The initiative will be applied to children without disturbing the parent-child relationship. The intervention will be applied for 10-15 minutes. The tell-show-do play therapy initiative will be implemented using the directed play therapy method and therapeutic play tools. Amigurumi dolls, medical toys (surgical shirt, movable toy bed) and real medical materials such as stethoscope, patient armband, bone, mask, degree will be used as therapeutic play tools. Receives: Other: Tell-show-do play therapy group |
| No intervention | Other | The participants in the control group will be given routine nursing care. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative anxiety of children
The decrease in anxiety levels of children whose attention is diverted with play dough and kaleidoscope is an outcome measure. This decrease will be measured with the "Modified Yale Preoperative Anxiety Scale". Outcome criteria will be evaluated twice in Pediatric Surgery Service, approximately 30 minutes before premedication and just before premedication (pretest-posttest). The scale consists of twenty-two items and five categories. Each category gets one point out of four. The higher the score on the scale, the greater anxiety. In the post-test, it will be evaluated whether there is a decrease according to the pre-test score. If there is a decrease in the "posttest" scores compared to the "pretest" scores, it can be said that distraction positively affects preoperative anxiety. Statistical significance will be set to p < 0.05.
Measured: Anxiety levels of children will be evaluated twice. The first measurement will be made 30 minutes before the premedication, and the last measurement will be made just before the premedication.
Preoperative anxiety of parent
The decrease in anxiety levels of parents of children whose attention is diverted with play dough and kaleidoscope is an outcome measure. This decrease will be measured by the "Spielberger State Anxiety Scale". Outcome criteria will be evaluated twice in Pediatric Surgery Service, approximately 30 minutes before premedication and just before premedication (pretest-posttest). The 4-point Likert-type scale, consisting of 20 items in total, measures the anxiety of the person at a certain time. For scores above 42 points, it indicates a high level of anxiety. In the post-test, it will be evaluated whether there is a decrease according to the pre-test score. If there is a decrease in the "posttest" scores compared to the "pretest" scores, it can be said that distraction positively affects preoperative anxiety. Statistical significance will be set to p < 0.05.
Measured: Anxiety levels of parents will be evaluated twice. The first measurement will be made 30 minutes before the premedication, and the last measurement will be made just before the premedication.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start18 Oct 2022
- Primary completion15 Mar 2026
- Study completion24 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preoperative CareStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isparta University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Akdeniz University
- Responsible party
- Sponsor
- Investigators
- Fahriye RN PAZARCIKCI, PhD, Study director, Isparta University of Applied SciencesEmine RN EFE, Professor, Study chair, Akdeniz UniversityŞevkiye DİKMEN, Study chair, Akdeniz UniversityÖznur ARAYAN, Study chair, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540041
- Sponsor's protocol ID
- IspartaUAS3
- Status last verified
- Oct 2024
- First submitted
- 9 Sep 2022
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Azher U, Srinath SK, Nayak M. Effectiveness of Bubble Breath Play Therapy in the Dental Management of Anxious Children: A Pilot Study. J Contemp Dent Pract. 2020 Jan 1;21(1):17-21.
PubMed 32381795Sridhar S, Suprabha BS, Shenoy R, Shwetha KT, Rao A. Effect of a relaxation training exercise on behaviour, anxiety, and pain during buccal infiltration anaesthesia in children: Randomized clinical trial. Int J Paediatr Dent. 2019 Sep;29(5):596-602. doi: 10.1111/ipd.12497. Epub 2019 Apr 8.
PubMed 30887592
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Bubble Breathing Play Therapy and Tell-show-do Play Therapy in the Preoperative Anxiety Children and Their Parent
- ClinicalTrials.gov ID
- NCT05540041
- Acronym / sponsor ID
- IspartaUAS3
- Conditions
- Preoperative Care, Child, Parents, Anxiety
- Keywords
- Preoperative Care, Child, Parents, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Isparta University of Applied SciencesUniversity, hospital or other
- Collaborators
- Akdeniz University
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 24 Mar 2026 (actual)
- First posted
- 14 Sep 2022 (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.
It is emphasized in studies that child and parent anxiety that arises in pediatric surgery should be prevented or reduced. According to previous studies, one way to reduce child and parent anxiety in the preoperative period is therapeutic play interventions. This study was planned to compare the effectiveness of two different therapeutic play interventions (bubble breathing play therapy and tell-show-do play therapy) in reducing preoperative anxiety of children and parents who are scheduled for elective surgery.
Detailed description
Aim: This study was planned to comparison of the effectiveness of two different therapeutic play interventions (bubble breathing play therapy and tell-show-do play therapy) in reducing preoperative anxiety of children and parents who are scheduled for elective surgery.
Method: This study was planned as a randomized controlled trial. The sample of the study will consist of 105 children aged 5-12, who will be operated on at Akdeniz University Hospital, and their parents. Randomization result; It was planned to include a total of 105 children and their parents in 3 groups: bubble breathing play therapy group (intervention group 1)= 35, tell-show-do play therapy group (intervention group 2)= 35 , and control group= 35 children and parents.
Child and parent information form will be used to collect data, Modified Yale Preoperative Anxiety Scale will be used to collect data in child sample, and Spielberger State Anxiety Scale will be used to collect data in parent sample.
Intervention and Data Collection: Randomization will be performed after the purpose of the study is explained to the child and parent who agreed to participate in the study and after obtaining consent. Immediately after the pretest (first measurement) is given to the children assigned to intervention group 1 and their parents, attempts to bubble breathing play therapy will be applied for 5-10 minutes. If they wish, the child and parents will be told that they can continue to play with the bubble toys until premedication. Children assigned to intervention group 2 and their parents will be tell-show-do play therapy for 10-15 minutes immediately after the pre-test (first measurement) is done. Participants randomized to the control group will be given routine standard nursing care. The second measurement will be just before premedication (post test). Thus, the effectiveness of the initiatives and their comparison with each other will be evaluated.
The data of the research will be analyzed using the Statistical Package of Social Science (SPSS) 23.0 software package program. The process of evaluating the data will be carried out with the support of a statistician.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Bubble breathing play therapy | Experimental | Other: Bubble breathing play therapy groupChildren in intervention group 2 will be given a bubble breathing play therapy intervention. With this intervention, it is aimed to teach the child and parent to breathe correctly and deeply, to relax them, to reduce their anxiety and fears, to relax, to direct their attention to something other than pain. In the intervention pediatric surgery service, investigative coaching will be applied 30 minutes before premedication. The procedure time is planned to be at least 5-10 minutes. The intervention will be implemented with a ready-made foam bubble toy. The toy will be provided by the researcher and given to the children as a gift. |
| Tell-show-do play therapy | Experimental | Other: Tell-show-do play therapy groupTell-show-do play therapy initiative will be applied to children included in intervention group 1. The initiative will be applied to children without disturbing the parent-child relationship. The intervention will be applied for 10-15 minutes. The tell-show-do play therapy initiative will be implemented using the directed play therapy method and therapeutic play tools. Amigurumi dolls, medical toys (surgical shirt, movable toy bed) and real medical materials such as stethoscope, patient armband, bone, mask, degree will be used as therapeutic play tools. |
| No intervention | Other | Other: No interventionThe participants in the control group will be given routine nursing care. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Being a child between the ages of 5-12 for which a surgical operation is planned
- Being the parent of a child between the ages of 5 and 12 whose surgical operation is planned
- Not having vision, hearing or speech problems
- Not have a mental or neurological disability
- Not being diagnosed with an anxiety disorder
Key exclusion criteria (2 listed)
- Change in surgical operation date
- Using another distraction technique
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 |
|---|---|---|
| Bubble breathing play therapy groupThe efficacy of bubble breathing play therapy in the preoperative anxiety children and their parent. | Other | Bubble breathing play therapy |
| Tell-show-do play therapy groupThe efficacy of tell-show-do play therapy in the preoperative anxiety children and their parent. | Other | Tell-show-do play therapy |
| No interventionRoutine nursing care | Other | No intervention |
Primary outcome
Preoperative anxiety of children
Time frame: Anxiety levels of children will be evaluated twice. The first measurement will be made 30 minutes before the premedication, and the last measurement will be made just before the premedication.
The decrease in anxiety levels of children whose attention is diverted with play dough and kaleidoscope is an outcome measure. This decrease will be measured with the "Modified Yale Preoperative Anxiety Scale". Outcome criteria will be evaluated twice in Pediatric Surgery Service, approximately 30 minutes before premedication and just before premedication (pretest-posttest). The scale consists of twenty-two items and five categories. Each category gets one point out of four. The higher the score on the scale, the greater anxiety. In the post-test, it will be evaluated whether there is a decrease according to the pre-test score. If there is a decrease in the "posttest" scores compared to the "pretest" scores, it can be said that distraction positively affects preoperative anxiety. Statistical significance will be set to p < 0.05.
Preoperative anxiety of parent
Time frame: Anxiety levels of parents will be evaluated twice. The first measurement will be made 30 minutes before the premedication, and the last measurement will be made just before the premedication.
The decrease in anxiety levels of parents of children whose attention is diverted with play dough and kaleidoscope is an outcome measure. This decrease will be measured by the "Spielberger State Anxiety Scale". Outcome criteria will be evaluated twice in Pediatric Surgery Service, approximately 30 minutes before premedication and just before premedication (pretest-posttest). The 4-point Likert-type scale, consisting of 20 items in total, measures the anxiety of the person at a certain time. For scores above 42 points, it indicates a high level of anxiety. In the post-test, it will be evaluated whether there is a decrease according to the pre-test score. If there is a decrease in the "posttest" scores compared to the "pretest" scores, it can be said that distraction positively affects preoperative anxiety. Statistical significance will be set to p < 0.05.
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 27 Mar 2026.
- Background: PubMed 32381795Azher U, Srinath SK, Nayak M. Effectiveness of Bubble Breath Play Therapy in the Dental Management of Anxious Children: A Pilot Study. J Contemp Dent Pract. 2020 Jan 1;21(1):17-21.
- Background: PubMed 30887592Sridhar S, Suprabha BS, Shenoy R, Shwetha KT, Rao A. Effect of a relaxation training exercise on behaviour, anxiety, and pain during buccal infiltration anaesthesia in children: Randomized clinical trial. Int J Paediatr Dent. 2019 Sep;29(5):596-602. doi: 10.1111/ipd.12497. Epub 2019 Apr 8.
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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.
Fahriye RN PAZARCIKCI, PhD study director
Isparta University of Applied Sciences
Emine RN EFE, Professor study chair
Akdeniz University
Şevkiye DİKMEN study chair
Akdeniz 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 Bubble breathing play therapy group and Tell-show-do play therapy group in people with Preoperative Care and Child, run by Isparta University of Applied Sciences 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 6 inclusion and 2 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 27 Mar 2026. 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?
Preoperative anxiety of children (time frame: Anxiety levels of children will be evaluated twice. The first measurement will be made 30 minutes before the premedication, and the last measurement will be made just before the premedication.). 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?
On the ClinicalTrials.gov record for NCT05540041, which also lists 2 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 27 Mar 2026.