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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05540041
• Other study ID #: IspartaUAS3
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: September 2022
• Source: Isparta University of Applied Sciences
• Contact: Fahriye RN PAZARCIKCI, PhD
• Phone: +902462117014
• Email: fahriyepazarcikci[@]isparta.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 30, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Child
• Parents
• Preoperative Care

Intervention

Other:
• Bubble breathing play therapy group
The efficacy of bubble breathing play therapy in the preoperative anxiety children and their parent.
• Tell-show-do play therapy group
The efficacy of tell-show-do play therapy in the preoperative anxiety children and their parent.
• No intervention
Routine nursing care

Locations

Country	Name	City	State
Turkey	Akdeniz University	Antalya	Antalya/Merkez

Sponsors (2)

Lead Sponsor	Collaborator
Isparta University of Applied Sciences	Akdeniz University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Primary	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.	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.