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Completed

NCT Number: NCT07274111

Virtual Reality as a Nursing Intervention for Anxiety and Pain in Pediatric Endoscopy

This randomized controlled trial aims to evaluate the effectiveness of a virtual reality (VR) intervention in managing anxiety, post-procedural pain, and recovery time among pediatric patients undergoing gastrointestinal (GI) endoscopy. The study is conducted at the Pediatric Gastrointestinal Endoscopy Unit, Mansoura University Children's Hospital, Egypt. Eligible children are randomly assigned to either a VR intervention group or a control group receiving standard care. The VR group uses a head-mounted display featuring age-appropriate immersive applications before endoscopy. Measured outcomes include anxiety levels, physiological stability, post-procedural pain, and recovery duration. The study follows CONSORT guidelines and ethical principles outlined in the Declaration of Helsinki.

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Key information

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, 35516, Egypt

About this study

This prospective randomized controlled experimental study investigates the use of virtual reality (VR) as a non-pharmacological nursing intervention to reduce anxiety and enhance recovery outcomes in pediatric patients undergoing gastrointestinal endoscopic procedures. The study is conducted at the Pediatric Gastrointestinal Endoscopy Unit of Mansoura University Children's Hospital, located in Mansoura City, Dakahlia Governorate, Egypt.

Participants include children aged 6-15 years scheduled for their first GI endoscopy who demonstrate an interest in technology and consent to participate. Children with seizure disorders, cardiac diseases, visual or hearing impairments, developmental delays, motion sickness, or those undergoing chemotherapy are excluded.

Following ethical approval and informed consent, participants are randomly allocated in a 1:1 ratio to either the VR intervention or control group. Both groups receive a standardized pre-procedural education session delivered by the endoscopist, anesthesiologist, and nurse. In the waiting area, baseline assessments include demographic characteristics, state and trait anxiety (using the State-Trait Anxiety Inventory for Children), physiological parameters (respiratory rate, heart rate, and oxygen saturation), and pain level (using the Wong-Baker FACES Pain Rating Scale).

Children in the VR group wear a head-mounted display containing preloaded age-appropriate immersive environments, such as virtual roller coasters, space exploration, wildlife parks, and travel scenes, for one minute before entering the endoscopy room. The nurse assists with headset adjustment and ensures proper device hygiene. The control group receives standard pre-procedural care without VR exposure.

Anxiety and physiological indicators are reassessed in the endoscopy room prior to anesthesia induction. Post-procedural pain and recovery duration (time spent in the recovery room until discharge) are recorded afterward. Data are analyzed using SPSS version 26, employing descriptive statistics, independent t-tests, chi-square tests, and non-parametric alternatives where appropriate. Statistical significance is set at p < .05.

This trial aligns with CONSORT reporting standards and aims to provide evidence on the clinical value of VR as an effective, child-friendly nursing intervention for anxiety and pain management in pediatric endoscopy settings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 6-15 years scheduled to undergo a gastrointestinal endoscopic procedure.
  • First-time endoscopy patients (no prior endoscopic experience).
  • Willing to participate, with informed consent from parents/guardians and child assent.

Interest in technology and ability to tolerate a brief VR experience.

  • Physically and cognitively able to complete the anxiety and pain assessment tools (STAI-CH and FACES scales).

Exclusion criteria

  • Children with a known history of seizure disorders or cardiac diseases.
  • Presence of active infection, burns, or trauma involving the periorbital skin, eyes, nasal bridge, external ear, scalp, or hair.
  • Visual or hearing impairments that would interfere with VR use.
  • Developmental delays (including autism spectrum disorders) that significantly limit cooperation or understanding of instructions.
  • Active psychosis or symptoms of intoxication.
  • History of severe motion sickness.
  • Children currently undergoing chemotherapy.

Treatment and study plan

Virtual Reality Head-Mounted Display

Behavioral

Children assigned to the experimental arm received a one-minute immersive session using a virtual reality head-mounted display before gastrointestinal endoscopy. The device contained age-appropriate preloaded applications featuring realistic visual and auditory environments, such as roller coasters, space exploration, wildlife parks, and travel scenes. The nurse assisted each child in properly fitting and adjusting the headset to ensure comfort and clarity. The VR session was administered immediately before transfer to the endoscopy room to reduce pre-procedural anxiety and enhance relaxation.

Other names: Immersive VR Session

Primary outcomes

  1. Change in Children's Anxiety Levels

    Time frame: Trait subscale was assessed only prior to the child's entry while the State subscale was assessed prior to entrance into the endoscopy room (pre-procedure) and before the induction of anesthesia (peri-procedure).

    Anxiety levels was measured using the State-Trait Anxiety Inventory for Children (STAI-CH). Both the trait and state subscales was used. The primary outcome was the difference in state anxiety scores before and during the intervention between the VR and control groups. Each item is scored on a 3-point Likert scale, with total scores ranging from 20 to 60, where higher scores indicate greater anxiety.

  2. Change in Pain Level

    Time frame: Two time points: pre-procedural pain level (immediately before entering the endoscopy room) and post-procedural pain level (30 minutes post-procedure in the recovery unit).

    pain will be measured using the Wong-Baker FACES Pain Rating Scale, which ranges from 0 (no pain) to 10 (worst pain). The outcome represents the mean difference in pain levels between the VR and control groups following the endoscopic procedure.

  3. Recovery Duration

    Time frame: Measured from the time of entry into the recovery room until discharge, assessed up to 300 minutes.

    Recovery time will be measured as the total duration of each child's stay in the recovery room (recorded in minutes and presented in hours) from entry into the recovery unit until discharge criteria are met. The outcome represents the mean recovery duration between the VR and control groups.

Secondary outcomes

  1. Change in respiratory rate

    Time frame: Respiratory rate was assessed immediately before entering the endoscopy room (pre-procedure) and again prior to anesthesia induction (peri-procedure).

    Respiratory rate was recorded in breaths per minute (bpm) using the bedside multiparameter monitor. The outcome reflects the mean change in respiratory rate between baseline and the peri-procedural time point.

  2. Change in heart rate

    Time frame: Heart rate was assessed prior to entrance into the endoscopy room (pre-procedure) and before the induction of anesthesia (peri-procedure).

    Heart rate was recorded in beats per minute using the bedside multiparameter monitor. The outcome reflects the mean change in heart rate between baseline and the peri-procedural time point.

  3. Change in Oxygen Saturation

    Time frame: Oxygen saturation was assessed prior to entrance into the endoscopy room (pre-procedure) and before the induction of anesthesia (peri-procedure).

    Oxygen saturation was measured using the bedside multiparameter monitor and expressed as a percentage (SpO₂). The outcome reflects the mean change in oxygen saturation between baseline and the peri-procedural time point.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Virtual Reality to Manage Pediatric Gastrointestinal Endoscope-related Anxiety, Post Procedural Pain, and Recovery Time: A Randomized Control Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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