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Reducing Anxiety of Children and Their Parents in the Pre-Operative Process With Therapeutic Play

Primary Purpose

Preoperative Care, Child, Parents

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bubble breathing play therapy group
Tell-show-do play therapy group
No intervention
Sponsored by
Isparta University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preoperative Care focused on measuring Preoperative Care, Child, Parents, Anxiety

Eligibility Criteria

5 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Change in surgical operation date
  • Using another distraction technique

Sites / Locations

  • Akdeniz UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Bubble breathing play therapy

Tell-show-do play therapy

No intervention

Arm Description

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.

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.

The participants in the control group will be given routine nursing care.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 9, 2022
Last Updated
January 16, 2023
Sponsor
Isparta University of Applied Sciences
Collaborators
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT05540041
Brief Title
Reducing Anxiety of Children and Their Parents in the Pre-Operative Process With Therapeutic Play
Official Title
The Efficacy of Bubble Breathing Play Therapy and Tell-show-do Play Therapy in the Preoperative Anxiety Children and Their Parent
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Isparta University of Applied Sciences
Collaborators
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preoperative Care, Child, Parents, Anxiety
Keywords
Preoperative Care, Child, Parents, Anxiety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Participant
Masking Description
Single (Participant)
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bubble breathing play therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Tell-show-do play therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
No intervention
Arm Type
Other
Arm Description
The participants in the control group will be given routine nursing care.
Intervention Type
Other
Intervention Name(s)
Bubble breathing play therapy group
Intervention Description
The efficacy of bubble breathing play therapy in the preoperative anxiety children and their parent.
Intervention Type
Other
Intervention Name(s)
Tell-show-do play therapy group
Intervention Description
The efficacy of tell-show-do play therapy in the preoperative anxiety children and their parent.
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
Routine nursing care
Primary Outcome Measure Information:
Title
Preoperative anxiety of children
Description
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.
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.
Title
Preoperative anxiety of parent
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Change in surgical operation date Using another distraction technique
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fahriye RN PAZARCIKCI, PhD
Phone
+902462117014
Email
fahriyepazarcikci@isparta.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Emine RN EFE, Professor
Phone
+902423106103
Email
eefe@akdeniz.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fahriye RN PAZARCIKCI, PhD
Organizational Affiliation
Isparta University of Applied Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Emine RN EFE, Professor
Organizational Affiliation
Akdeniz University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Şevkiye DİKMEN
Organizational Affiliation
Akdeniz University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Öznur ARAYAN
Organizational Affiliation
Akdeniz University
Official's Role
Study Chair
Facility Information:
Facility Name
Akdeniz University
City
Antalya
State/Province
Antalya/Merkez
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fahriye Pazarcıkcı, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
32381795
Citation
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.
Results Reference
background
PubMed Identifier
30887592
Citation
Sridhar 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.
Results Reference
background

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Reducing Anxiety of Children and Their Parents in the Pre-Operative Process With Therapeutic Play

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