Preoperative AnxietyVAPiCNCT07128056
Effect of Mobile Phone Video Games on Preoperative Anxiety and Postoperative Pain in Children
A study testing Mobile phone video game distraction and Standard peri operative care in people with Preoperative Anxiety and Postoperative Pain, run by Fatima Numeri at 1 site in Pakistan.
Trial summary
This randomized controlled trial will evaluate the effect of mobile phone video game distraction on preoperative anxiety and postoperative pain in pediatric surgical patients. Children aged 3-12 years undergoing elective surgery under general anesthesia will be randomly assigned to either a video game distraction… Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Preoperative Anxiety, Postoperative Pain, Elective Surgical Procedure
- What is being tested?
- Mobile phone video game distraction and Standard peri operative care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Aug 2025to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3-12y
- Children undergoing elective surgery
- Has access to a Mobile phone
- Is able to speak in urdu
- Children with no contraindications for the use of video games
Who cannot join
- Children with previous surgical experience
- Children with cognitive and learning disabilities
- Children with a chronic illness/pain that required special medical care
- Not familiar with video games
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Department of Pediatric Surgery ,Services Institute of Medical Sciences/Services Hospital Lahore
Lahore, Punjab Province, 54000
Prof Dr Fatima Naumeri Professor of Pediatric Surgery, FCPS,MCPS-HPE,MCPS,CME, +92 321 4017065, Fatimanaumeri@gmail.com
Dr Huma Imtiaz Postgraduate Resident,Pediatric surgery department,SIMS, MBBS, +92 305 3864695, humaimtiaz60@gmail.com
About this study
Official title: Effect of Mobile Phone Video Games on Preoperative Anxiety and Postoperative Pain in Children Undergoing Elective Surgery
This randomized controlled trial will evaluate the effect of mobile phone video game distraction on preoperative anxiety and postoperative pain in pediatric surgical patients. Children aged 3-12 years undergoing elective surgery under general anesthesia will be randomly assigned to either a video game distraction group or a control group receiving standard perioperative care. The primary outcomes are preoperative anxiety levels and postoperative pain scores. The study aims to determine whether a simple, low-cost behavioral intervention can improve perioperative experiences in children
Read the detailed description
Preoperative anxiety and postoperative pain are common problems among pediatric patients undergoing surgery. Children often experience high levels of anxiety before a surgical procedure, and this preoperative anxiety can have long-term negative outcomes. Surgical tissue damage leads to moderate to severe postoperative pain, and preoperative anxiety is a significant predictor of postoperative pain. Inadequate pain management can result in delayed recovery, diminished quality of life, increased healthcare costs, and higher healthcare utilization.
Both pharmacological and non-pharmacological methods are used to manage preoperative anxiety and postoperative pain. However, pharmacological medications may have undesirable side effects, and non-pharmacological interventions such as music therapy, clown presence, or parental presence may not be feasible in the operating theatre environment.
Video games (VGs) are increasingly used in healthcare as distraction tools and for behavior modification therapy. Mobile phones are widely available, and playing video games has become a common activity in society. Children can become deeply engaged in playing VGs, which may reduce their awareness of the surgical environment and lower their anxiety levels. Reduced preoperative anxiety may, in turn, lead to decreased postoperative pain.
There is a lack of local research on the use of mobile phone video games in pediatric perioperative care. This study aims to evaluate the effect of mobile phone video games in reducing preoperative anxiety and postoperative pain, and to determine whether this intervention can be recommended for pediatric surgeries.
A randomized controlled trial will be conducted in the Department of Pediatric Surgery, Services Hospital Lahore, over 12 months. Children aged 3-12 years undergoing low-risk elective surgery will be enrolled. Informed consent will be obtained from parents or guardians. Participants will be randomized via the lottery method into:
- Experimental group: Mobile phone video game distraction (n=75)
- Control group: Standard perioperative care (n=75)
Anxiety will be measured at two points:
- T1: In the preoperative waiting room
- T2: After playing video games for 20 minutes, before induction of anesthesia in the operating room
The Modified Yale Preoperative Anxiety Scale - Short Form (m-YPAS-SF) will be used, where scores range from 22.92 to 100, with lower scores indicating lower anxiety. Postoperative pain will be assessed in the ward using the Revised Faces Pain Scale (r-FACES).
Data will be analyzed using SPSS v25. Numerical variables will be summarized as mean ± standard deviation, and categorical variables as frequencies and percentages. Independent sample t-tests will be used for numerical variables, and Chi-square tests for categorical variables. Data will be stratified for age, gender, and weight to control for effect modifiers. A p-value ≤ 0.05 will be considered statistically significant.
Preoperative anxiety management is a relatively neglected area in Pakistan, and international recommendations are not always applicable in resource-limited settings. The findings from this single-center clinical trial will provide evidence for local clinical practice and may serve as a framework for developing regional protocols to prevent adverse postoperative outcomes.
Limitations: Single-center design and the need for additional staff and time to conduct the study
- Being tested
- Mobile phone video game distraction, Standard peri operative care
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile phone video game distractionBehavioural
Children in the intervention group will play age-appropriate, non-violent mobile phone video games for approximately 20 minutes before induction of anesthesia. This is intended as a distraction technique to reduce preoperative anxiety and improve postoperative pain outcomes. Participants will also receive standard perioperative care.
Standard peri operative careOther
Standard preoperative and postoperative care according to institutional protocol, without mobile phone video game distraction.
| Study group | Role | What they receive |
|---|---|---|
| Mobile phone video game distraction | Experimental | Participants will play age-appropriate, non-violent mobile phone video games for approximately 20 minutes before induction of anesthesia as a distraction technique, in addition to receiving standard perioperative care Receives: Behavioral: Mobile phone video game distraction; Other: Standard peri operative care |
| Standard perioperative care | Active comparator | Participants will receive standard perioperative care according to institutional protocols, without exposure to the mobile phone video game distraction Receives: Other: Standard peri operative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Anxiety Level
Anxiety will be measured at two time points (T1 and T2). At T1, baseline anxiety will be assessed in the preoperative waiting room. Children randomized to the intervention group will then play mobile phone video games for 20 minutes, while the control group will not. At T2, anxiety will be reassessed immediately before induction of anesthesia in the operating room. Anxiety will be measured using the modified Yale Preoperative Anxiety Scale - Short Form (m-YPAS-SF), where scores range from 22.92 to 100, with lower scores indicating lower anxiety.
Measured: Measured twice - (T1) in the preoperative waiting area before intervention, and (T2) after 20 minutes of mobile phone video game distraction, immediately before induction of anesthesia.
Postoperative Pain Intensity
Post operative pain management will be standardized and it will be measured at 1 and 12 hours after surgery using revised faces pain scale (FPS-r) in the ward.It consists of six faces showing progressively increasing levels of distress with each face assigned a numerical value 0-10.
Measured: It will be measured at 1 and 12 hours after surgery in the ward.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, parallel-group trial in which pediatric patients undergoing elective surgery will be allocated in a 1:1 ratio to either the intervention arm, receiving mobile phone video game play in addition to standard perioperative care, or the control arm, receiving standard perioperative care alone. Both groups will be assessed for preoperative anxiety and postoperative pain using validated pediatric scales at specified time points.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatima Numeri
- Sponsor type
- Other government
- Collaborators
- Services Institute of Medical Sciences, Pakistan
- Responsible party
- Sponsor-investigator, Fatima Numeri, Services Institute of Medical Sciences, Pakistan
- Investigators
- Prof Dr Fatima Naumeri, FCPS,MCPS-HPE,MCPS,CME, Study director, Services Institute of Medical Sciences, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128056
- Sponsor's protocol ID
- PEDS-ANXPAIN-2025-01
- Other IDs
- IRB/2024/1434/SIMS
- Acronym
- VAPiC
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bezgin S, Kuyulu S, Atıcı A. Investigation of the effect of video-based game application on acute pain in children under surgery. Journal of Health Sciences and Medicine. 2025;8(1):115-118. doi:10.32322/jhsm.123456
Teruel J, Stafford G, Brown J, Jones B, Hopkins M, Johnson A, Edenfield J, Guo A, Schammel C, Renfro S, Nisonson A. Reduction of perioperative anxiety using a hand-held video game device: A randomized study. Perioperative Care and Operating Room Management. 2021 Dec;24:100203. doi:10.1016/j.pcorm.2021.100203.
Rostami E, Khanjari S, Haghani H, Amirian H. Effect of video games on preoperative anxiety in 3- to-6-year-old of a sample of Iranian children undergoing elective surgery. J Educ Health Promot. 2022 Apr 28;11:135. doi: 10.4103/jehp.jehp_455_21. eCollection 2022.
PubMed 35677284Mustafa MS, Shafique MA, Zaidi SDEZ, Qamber A, Rangwala BS, Ahmed A, Zaidi SMF, Rangwala HS, Uddin MMN, Ali M, Siddiq MA, Haseeb A. Preoperative anxiety management in pediatric patients: a systemic review and meta-analysis of randomized controlled trials on the efficacy of distraction techniques. Front Pediatr. 2024 Feb 19;12:1353508. doi: 10.3389/fped.2024.1353508. eCollection 2024.
PubMed 38440185Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.
PubMed 16882820Ali MA, Khan MH, Salim B. Comparing Pharmacological and Nonpharmacological Interventions for Alleviating Preoperative Anxiety in Pediatric Surgical Patients: A Randomized Controlled Trial in Pakistan. Cureus. 2025 Apr 18;17(4):e82502. doi: 10.7759/cureus.82502. eCollection 2025 Apr.
PubMed 40385813
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mobile Phone Video Games on Preoperative Anxiety and Postoperative Pain in Children Undergoing Elective Surgery
- ClinicalTrials.gov ID
- NCT07128056
- Acronym / sponsor ID
- VAPiC / PEDS-ANXPAIN-2025-01
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fatima NumeriOther government
- Collaborators
- Services Institute of Medical Sciences, Pakistan
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial will evaluate the effect of mobile phone video game distraction on preoperative anxiety and postoperative pain in pediatric surgical patients. Children aged 3-12 years undergoing elective surgery under general anesthesia will be randomly assigned to either a video game distraction group or a control group receiving standard perioperative care. The primary outcomes are preoperative anxiety levels and postoperative pain scores. The study aims to determine whether a simple, low-cost behavioral intervention can improve perioperative experiences in children
Detailed description
Preoperative anxiety and postoperative pain are common problems among pediatric patients undergoing surgery. Children often experience high levels of anxiety before a surgical procedure, and this preoperative anxiety can have long-term negative outcomes. Surgical tissue damage leads to moderate to severe postoperative pain, and preoperative anxiety is a significant predictor of postoperative pain. Inadequate pain management can result in delayed recovery, diminished quality of life, increased healthcare costs, and higher healthcare utilization.
Both pharmacological and non-pharmacological methods are used to manage preoperative anxiety and postoperative pain. However, pharmacological medications may have undesirable side effects, and non-pharmacological interventions such as music therapy, clown presence, or parental presence may not be feasible in the operating theatre environment.
Video games (VGs) are increasingly used in healthcare as distraction tools and for behavior modification therapy. Mobile phones are widely available, and playing video games has become a common activity in society. Children can become deeply engaged in playing VGs, which may reduce their awareness of the surgical environment and lower their anxiety levels. Reduced preoperative anxiety may, in turn, lead to decreased postoperative pain.
There is a lack of local research on the use of mobile phone video games in pediatric perioperative care. This study aims to evaluate the effect of mobile phone video games in reducing preoperative anxiety and postoperative pain, and to determine whether this intervention can be recommended for pediatric surgeries.
A randomized controlled trial will be conducted in the Department of Pediatric Surgery, Services Hospital Lahore, over 12 months. Children aged 3-12 years undergoing low-risk elective surgery will be enrolled. Informed consent will be obtained from parents or guardians. Participants will be randomized via the lottery method into:
- Experimental group: Mobile phone video game distraction (n=75)
- Control group: Standard perioperative care (n=75)
Anxiety will be measured at two points:
- T1: In the preoperative waiting room
- T2: After playing video games for 20 minutes, before induction of anesthesia in the operating room
The Modified Yale Preoperative Anxiety Scale - Short Form (m-YPAS-SF) will be used, where scores range from 22.92 to 100, with lower scores indicating lower anxiety. Postoperative pain will be assessed in the ward using the Revised Faces Pain Scale (r-FACES).
Data will be analyzed using SPSS v25. Numerical variables will be summarized as mean ± standard deviation, and categorical variables as frequencies and percentages. Independent sample t-tests will be used for numerical variables, and Chi-square tests for categorical variables. Data will be stratified for age, gender, and weight to control for effect modifiers. A p-value ≤ 0.05 will be considered statistically significant.
Preoperative anxiety management is a relatively neglected area in Pakistan, and international recommendations are not always applicable in resource-limited settings. The findings from this single-center clinical trial will provide evidence for local clinical practice and may serve as a framework for developing regional protocols to prevent adverse postoperative outcomes.
Limitations: Single-center design and the need for additional staff and time to conduct the study
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group trial in which pediatric patients undergoing elective surgery will be allocated in a 1:1 ratio to either the intervention arm, receiving mobile phone video game play in addition to standard perioperative care, or the control arm, receiving standard perioperative care alone. Both groups will be assessed for preoperative anxiety and postoperative pain using validated pediatric scales at specified time points.
| Arm | Type | Receives |
|---|---|---|
| Mobile phone video game distraction | Experimental | Behavioral: Mobile phone video game distraction, Other: Standard peri operative careParticipants will play age-appropriate, non-violent mobile phone video games for approximately 20 minutes before induction of anesthesia as a distraction technique, in addition to receiving standard perioperative care |
| Standard perioperative care | Active comparator | Other: Standard peri operative careParticipants will receive standard perioperative care according to institutional protocols, without exposure to the mobile phone video game distraction |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 3-12y
- Children undergoing elective surgery
- Has access to a Mobile phone
- Is able to speak in urdu
- Children with no contraindications for the use of video games
Key exclusion criteria (4 listed)
- Children with previous surgical experience
- Children with cognitive and learning disabilities
- Children with a chronic illness/pain that required special medical care
- Not familiar with video games
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile phone video game distractionChildren in the intervention group will play age-appropriate, non-violent mobile phone video games for approximately 20 minutes before induction of anesthesia. This is intended as a distraction technique to reduce preoperative anxiety and improve postoperative pain outcomes. Participants will also receive standard perioperative care. | Behavioural | Mobile phone video game distraction |
| Standard peri operative careStandard preoperative and postoperative care according to institutional protocol, without mobile phone video game distraction. | Other | Mobile phone video game distraction, Standard perioperative care |
Primary outcome
Preoperative Anxiety Level
Time frame: Measured twice - (T1) in the preoperative waiting area before intervention, and (T2) after 20 minutes of mobile phone video game distraction, immediately before induction of anesthesia.
Anxiety will be measured at two time points (T1 and T2). At T1, baseline anxiety will be assessed in the preoperative waiting room. Children randomized to the intervention group will then play mobile phone video games for 20 minutes, while the control group will not. At T2, anxiety will be reassessed immediately before induction of anesthesia in the operating room. Anxiety will be measured using the modified Yale Preoperative Anxiety Scale - Short Form (m-YPAS-SF), where scores range from 22.92 to 100, with lower scores indicating lower anxiety.
Postoperative Pain Intensity
Time frame: It will be measured at 1 and 12 hours after surgery in the ward.
Post operative pain management will be standardized and it will be measured at 1 and 12 hours after surgery using revised faces pain scale (FPS-r) in the ward.It consists of six faces showing progressively increasing levels of distress with each face assigned a numerical value 0-10.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- BackgroundBezgin S, Kuyulu S, Atıcı A. Investigation of the effect of video-based game application on acute pain in children under surgery. Journal of Health Sciences and Medicine. 2025;8(1):115-118. doi:10.32322/jhsm.123456
- BackgroundTeruel J, Stafford G, Brown J, Jones B, Hopkins M, Johnson A, Edenfield J, Guo A, Schammel C, Renfro S, Nisonson A. Reduction of perioperative anxiety using a hand-held video game device: A randomized study. Perioperative Care and Operating Room Management. 2021 Dec;24:100203. doi:10.1016/j.pcorm.2021.100203.
- Background: PubMed 35677284Rostami E, Khanjari S, Haghani H, Amirian H. Effect of video games on preoperative anxiety in 3- to-6-year-old of a sample of Iranian children undergoing elective surgery. J Educ Health Promot. 2022 Apr 28;11:135. doi: 10.4103/jehp.jehp_455_21. eCollection 2022.
- Background: PubMed 38440185Mustafa MS, Shafique MA, Zaidi SDEZ, Qamber A, Rangwala BS, Ahmed A, Zaidi SMF, Rangwala HS, Uddin MMN, Ali M, Siddiq MA, Haseeb A. Preoperative anxiety management in pediatric patients: a systemic review and meta-analysis of randomized controlled trials on the efficacy of distraction techniques. Front Pediatr. 2024 Feb 19;12:1353508. doi: 10.3389/fped.2024.1353508. eCollection 2024.
- Background: PubMed 16882820Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.
- Background: PubMed 40385813Ali MA, Khan MH, Salim B. Comparing Pharmacological and Nonpharmacological Interventions for Alleviating Preoperative Anxiety in Pediatric Surgical Patients: A Randomized Controlled Trial in Pakistan. Cureus. 2025 Apr 18;17(4):e82502. doi: 10.7759/cureus.82502. eCollection 2025 Apr.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof Dr Fatima Naumeri, FCPS,MCPS-HPE,MCPS,CME study director
Services Institute of Medical Sciences, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile phone video game distraction and Standard peri operative care in people with Preoperative Anxiety and Postoperative Pain, run by Fatima Numeri at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Huma Imtiaz, MBBS (+92 305 3864695, humaimtiaz60@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Anxiety Level (time frame: Measured twice - (T1) in the preoperative waiting area before intervention, and (T2) after 20 minutes of mobile phone video game distraction, immediately before induction of anesthesia.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07128056, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.