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

NCT05540041 | Completed

• 1 other identifier: IspartaUAS3
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Preoperative Care; Parents; Anxiety; Child

Keywords

Preoperative Care; Child; Parents; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (3)

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.

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.

Other: Tell-show-do play therapy group

No intervention

OTHER

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

Other: No intervention

Interventions

Bubble breathing play therapy group OTHER

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

Bubble breathing play therapy

Tell-show-do play therapy group OTHER

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

Tell-show-do play therapy

No intervention OTHER

Routine nursing care

No intervention

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Change in surgical operation date
• Using another distraction technique

Sponsors & Collaborators

• Isparta University of Applied Sciences: lead
• Akdeniz University: collaborator

Study Sites (1)

Akdeniz University

Antalya, Antalya/Merkez, Turkey (Türkiye)

Location

Related 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.

  PMID: 32381795 BACKGROUND

• 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.

  PMID: 30887592 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Fahriye RN PAZARCIKCI, PhD

  Isparta University of Applied Sciences

  STUDY DIRECTOR

• Emine RN EFE, Professor

  Akdeniz University

  STUDY CHAIR

• Şevkiye DİKMEN

  Akdeniz University

  STUDY CHAIR

• Öznur ARAYAN

  Akdeniz University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 14, 2022
• Study Start: October 18, 2022
• Primary Completion: March 15, 2026
• Study Completion: March 24, 2026
• Last Updated: March 27, 2026

Record last verified: 2024-10

Locations

TU (1)