Effect Of Virtual Reality Glasses Used During Splint Application On Children's Pain And Anxiety Levels.

NCT05281133 | Completed

• 1 other identifier: KBU-SBE-CK-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The study in order to evaluate the effect of virtual reality glasses during splint in children on pain and anxiety due to the procedure.

Conditions

Pain, Acute; Anxiety Acute; Fractures, Bone

Keywords

Anxiety; child; fracture; nurse; pain; splint; virtual reality glasses

Outcome Measures

Primary Outcomes (2)

• Wong Baker Pain Scale- (FACES)

  Wong Baker Faces Pain Rating Scale was developed by Wong and Baker (1981) and was reorganized in 1983. It is employed in the diagnosis of pain severity in 3e18 years-old children. It includes a zero (0) to five (5) scoring system. It is a horizontal scale of 6 hand-drawn faces, from 0 to 5, that range from a smiling "no hurt" face on the left followed by "hurts little bit", "hurts little more", "hurts even more", "hurts whole lot" to a crying "hurts worst" face on the right and scoring is conducted according to the image.

  six months

• State-Trait Anxiety Inventory for Children- (STAI-CH)

  State-Trait Anxiety Inventory for Children is the scale developed Spielberg's (1966) for testing anxiety. Children are asked to assess how they feel at the moment and to mark the most appropriate option. For each of the 20 items to evaluate the level of anxiety, one of the options (scored as 1, 2 or 3) is marked according to the presence and severity of the symptom. Turkish adaptation, validity and reliability study of this scale was done by Şeniz Özusta (1993). The scale, which consists of twenty items, aims to evaluate the emotions associated with state anxiety such as tension, nervousness, perturbation, and haste. When the presence of these emotions is reported as "very much so" by the child, the highest score is 3 and the lowest score of 1is assigned when "not at all" is preferred. The highest score in the scale is 60 and the lowest score is 20.

  six months

Study Arms (2)

The group using virtual reality glasses

EXPERIMENTAL

The video chosen by the children in the experimental group was started 1-2 minutes before the splint with virtual reality glasses and watched for an average of 7 minutes.

Other: The group using virtual reality glasses

The group not using virtual reality glasses

NO INTERVENTION

In the control group, during the splint a video was not watched.

Interventions

The group using virtual reality glasses OTHER

The video chosen by the children in the experimental group was started 1-2 minutes before the splint with virtual reality glasses and watched for an average of 7 minutes.

The group using virtual reality glasses

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The child should be between the ages of 6 and 12 age old.
• Acceptance of the research and giving written consent by the family and the child.
• Ability of the family and child to speak Turkish.
• The child should not wear glasses.
• The child should be at a cognitive level able to choose videos.

You may not qualify if:

• The child should have chronic diseases.
• The child should take analgesics with in the last 24 hours.
• The child should have physical, mental and neurological disabilities.
• The child has a febrile illness.
• Fainting of the child during the procedure.

Sponsors & Collaborators

• Karabuk University: lead

Study Sites (1)

Institute of Health Sciences Karabuk University

Karabük, Merkez/Turkey, 78050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Pain; Fractures, Bone; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Mental Disorders

Study Officials

• Özlem Öztürk Şahin, ass. prof.

  Karabuk University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: A total of 80 children assigned by randomization method (experimental group=40, control group= 40) were included in the sample group. The "Participant Information Form", the "Practice Registration Form", the "Wong Baker Pain Scale", the "State Anxiety Inventory for Children", the "After Splint Child's General Condition Evaluation Form", virtual reality glasses and pulse oximeter were used to collect data by outcomes assessor. Pain, anxiety and vital signs of the children in the experimental and control groups were recorded before, during and after the splint. The video chosen by the children in the experimental group was started 1-2 minutes before the splint with virtual reality glasses and watched for an average of 7 minutes. In the control group, during the splint a video was not watched.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study was carried out as a randomized controlled. In the study, two groups consisted of experimental group (n=40) and control group (n=40) were determined.

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 16, 2022
• Study Start: May 1, 2021
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: March 16, 2022

Record last verified: 2022-03

Locations

TU (1)