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

Sponsor

Isparta University of Applied Sciences (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05540041

Collaborator

Akdeniz University (Other)

210

Enrollment

Arms

5.5

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Preoperative Care Child Parents Anxiety	Other: Bubble breathing play therapy group Other: Tell-show-do play therapy group Other: No intervention	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel AssignmentParallel Assignment

Masking:

Single (Participant)

Masking Description:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

The Efficacy of Bubble Breathing Play Therapy and Tell-show-do Play Therapy in the Preoperative Anxiety Children and Their Parent

Anticipated Study Start Date :

Sep 30, 2022

Anticipated Primary Completion Date :

Oct 15, 2022

Anticipated Study Completion Date :

Mar 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bubble breathing play therapy 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.	Other: Bubble breathing play therapy group The efficacy of bubble breathing play therapy in the preoperative anxiety children and their parent.
Experimental: Tell-show-do play therapy 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.	Other: Tell-show-do play therapy group The efficacy of tell-show-do play therapy in the preoperative anxiety children and their parent.
Other: No intervention The participants in the control group will be given routine nursing care.	Other: No intervention Routine nursing care

Arm

Intervention/Treatment

Experimental: Bubble breathing play therapy

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.

Other: Bubble breathing play therapy group

The efficacy of bubble breathing play therapy in the preoperative anxiety children and their parent.

Experimental: Tell-show-do play therapy

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.

Other: Tell-show-do play therapy group

The efficacy of tell-show-do play therapy in the preoperative anxiety children and their parent.

Other: No intervention

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

Other: No intervention

Routine nursing care

Outcome Measures

Primary Outcome Measures

Preoperative anxiety of children [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Isparta University of Applied Sciences
Akdeniz University

Investigators

Study Director: Fahriye RN PAZARCIKCI, PhD, Isparta University of Applied Sciences
Study Chair: Emine RN EFE, Professor, Akdeniz University
Study Chair: Şevkiye DİKMEN, Akdeniz University
Study Chair: Öznur ARAYAN, Akdeniz University