NCT05543876

Brief Summary

IInvasive procedures such as suturing cause pain and fear in children. The high level of pain and fear of children makes it difficult to adapt to the procedure. It is a randomized controlled study planned to examine the effect of watching videos with virtual reality glasses as a distraction method while suturing in 7-12 age group children. Araştırma Acil Müdahale Odasında 01 Ekim 2022-31 Mart 2023 tarihlerinde yürütülmesi planlanmaktadır. In the collection of data; It is planned to use the Child Information Form, Wong-Baker Pain Scale, Child Fear Scale, which was created as a result of the literature review.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

1.7 years

First QC Date

September 13, 2022

Last Update Submit

January 17, 2024

Conditions

Keywords

suturevirtual reality glassespainfearchild

Outcome Measures

Primary Outcomes (12)

  • Wong Baker Pain score of the intervention group before the suture procedure

    Wong Baker Pain Score; The pain level of the faces on the scale is explained to the child: "0=no pain……..10=unbearably severe pain".According to the scoring; 0-4 means mild pain, 5-6 moderate, 7-8 severe, 9-10 unbearable pain.

    Wong Baker pain score of the intervention group three minutes before the suture procedure

  • Wong Baker Pain Score during suture procedure of the intervention group

    Wong Baker Pain Score; The pain level of the faces on the scale is explained to the child: "0=no pain……..10=unbearably severe pain".According to the scoring; 0-4 means mild pain, 5-6 moderate, 7-8 severe, 9-10 unbearable pain.

    Wong Baker Pain Score at the time of suturing of the intervention group

  • Wong Baker Pain Score of the control group before suture procedure

    Wong Baker Pain Score; The pain level of the faces on the scale is explained to the child: "0=no pain……..10=unbearably severe pain".According to the scoring; 0-4 means mild pain, 5-6 moderate, 7-8 severe, 9-10 unbearable pain.

    Wong Baker Pain Score of the control group three minutes before the suture procedure

  • Wong Baker Pain Score during suture procedure of the control group

    Wong Baker Pain Score;The pain level of the faces on the scale is explained to the child: "0=no pain……..10=unbearably severe pain".According to the scoring; 0-4 means mild pain, 5-6 moderate, 7-8 severe, 9-10 unbearable pain.

    Wong Baker Pain Score at the time of suturing of the control group

  • Child Fear Scale Score before the suture procedure of the intervention group

    Child Fear Scale Score; It consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) with scores ranging from 0-4.

    Child Fear Scale Score 3 minutes before suture of the intervention group

  • Child Fear Scale Score during the suture procedure of the intervention group

    Child Fear Scale Score; It consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) with scores ranging from 0-4.

    Child Fear Score at the time of suturing of the intervention group

  • Child Fear Scale Score before the suture procedure of the control group

    Child Fear Scale Score; It consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) with scores ranging from 0-4.

    Child Fear Scale Score 3 minutes before suture of the control group

  • Child Fear Scale Score during the suture procedure of the control group

    Child Fear Scale Score;It consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) with scores ranging from 0-4.

    Child Fear Score at the time of suturing of the control group

  • Wong Baker Pain score of the intervention group after the suture procedure

    Wong Baker Pain ScoreThe pain level of the faces on the scale is explained to the child: "0=no pain……..10=unbearably severe pain".According to the scoring; 0-4 means mild pain, 5-6 moderate, 7-8 severe, 9-10 unbearable pain.;

    Wong Baker pain score of the intervention group three minutes after the suture procedure

  • Wong Baker Pain Score of the control group after suture procedure

    Wong Baker Pain Score; The pain level of the faces on the scale is explained to the child: "0=no pain……..10=unbearably severe pain".According to the scoring; 0-4 means mild pain, 5-6 moderate, 7-8 severe, 9-10 unbearable pain.

    Wong Baker pain score of the control group three minutes after the suture procedure

  • Child Fear Scale Score of the intervention group after the suture procedure

    Child Fear Scale Score;It consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) with scores ranging from 0-4.

    Child Fear Scale Score of the intervention group three minutes after the suture procedure

  • Child Fear Scale Score of the control group after the suture procedure

    Child Fear Scale Score;It consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) with scores ranging from 0-4.

    Child Fear Scale Score of the control group three minutes after the suture procedure

Study Arms (2)

intervention group

EXPERIMENTAL

group watching video with virtual reality glasses

Procedure: suturing procedure

control group

NO INTERVENTION

without any intervention

Interventions

Children presenting to the emergency department for suturing

intervention group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 7-12 years,
  • Suture the emergency room on 01 October 2022 - 31 March 2023 children applying for expulsion,
  • Informed volunteer signers (child and parent),
  • Children without mental and developmental retardation,
  • No history of epilepsy,
  • Have not taken painkillers in the last 6 hours,
  • There will be no stitches around the eyes and head (where the virtual reality glasses will coincide) kids
  • They are children who can speak and communicate in Turkish.

You may not qualify if:

  • Children under 7 years old and over 12 years old,
  • Children who applied to the emergency room for suturing except between 01 October 2022 - 31 March 2023,
  • Those who did not sign the informed consent form (child and parent),
  • Children with mental and developmental retardation, with a history of epilepsy,
  • Have taken painkillers in the last 6 hours,
  • Stitches will be placed around the eyes and head (where the virtual reality glasses will coincide) kids
  • These are children who cannot speak Turkish and cannot be communicated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin Toros Public Hospital

Mersin, Akdeniz, 33343, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Artuvan Z, Cetin H, Turkmen AS. The effect of watching videos with virtual reality glasses on pain and fear in children who undergoing suturing in the emergency department: A randomized controlled trial. J Pediatr Nurs. 2025 May-Jun;82:31-37. doi: 10.1016/j.pedn.2025.02.017. Epub 2025 Feb 28.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hacer Çetin

    Mersin University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Specialist Nurse

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 16, 2022

Study Start

October 1, 2022

Primary Completion

June 30, 2024

Study Completion

July 31, 2024

Last Updated

January 18, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations