Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2025-12-15 @ 10:04 PM
Study NCT ID:
NCT06247800
Status:
None
Last Update Posted:
2025-11-19 00:00:00
First Post:
2024-01-15 00:00:00
Brief Title:
Virtual Reality: Distraction During Small Bore Intercostal Chest Drain Insertion
Sponsor:
National University of Malaysia
Organization:
National University of Malaysia
Study Overview
Official Title:
Virtual Reality: Satisfaction and Tolerability as a Distraction During Small Bore Intercostal Chest Drain Insertion an Open Label Randomized Control Trial
Status:
None
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VR-STICH
Brief Summary:
Research Questions Can Virtual Reality serve as a diversion and improve participant's satisfaction and tolerability during the insertion of a small-bore intercostal chest drain?
Hypothesis VR leads to better satisfaction of participant during ICC insertion VR reduce pain and anxiety during ICC insertion VR leads to better satisfaction of proceduralist during ICC insertion
Type of Study This is a single center, prospective, interventional study of in-patient participants who are diagnosed with pleural disease and under follow up Respiratory Unit Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia. All participants involved in the study will be randomized by 4 block randomizations into either interventional group (VR) or control group (without VR). All participants will be undergoing small bore ICC drain on top of standard care during procedure.
Demographic data was collected prior to randomization, which included (age, gender, ethnicity, BMI, comorbidities) and indications for ICC. The investigator then randomized into 2 groups via block randomization into intervention (VR) and controlled group (without VR).
Subsequently, consent will be obtained from those who are agree to participate, either from the participant him/herself or their next-of-kin. The process of briefing and obtaining consent will be only done once the participant is stable. These processes will not in any way interfering with clinical evaluation, investigation, treatment and intervention done to the participant by the attending doctor. All of the consented participants will be undergoing ICC insertion.
Prior to the ICC insertion, vital signs will be recorded and both groups will be given a VAS questionnaire to assess their pain and breathlessness. This is done to determine the participant's baseline score pre-procedure. The pain score was measured by the use of validated 10 cm VAS, a 10 cm line anchored with "no pain" at 0 cm and "unbearable pain" at 10 cm. The breathlessness VAS was measured with a similar scale which was anchored with "no breathlessness" at 0 cm, and "worst possible breathlessness" at 10 cm. Participants will also be given State-Trait-Anxiety-Inventory (STAI) questionnaire. It comprised of twenty statements that assess how respondents feel "at the present time.". They were instructed to circle the number that describes the intensity of their feelings concerning each question best: 1, "not at all;" 2, "somewhat;" 3, "moderately so;" 4, "very much so.". The STAI has a potential score range spanning from 20 to 80, and our study employed both English and a verified translated version in Malay for the questionnaire.
After completing the questionnaires, participants in the interventional group will be given the virtual reality (VR) device to wear, which was the Oculus Quest 2 (Oculus, China) before ICC insertion. The device is owned by respiratory unit HCTM and had been utilized in previous study. Videos of natural scenery were played for them while calming instrumental music played in the background. Three-dimensional footage of natural landscapes from across the world was played as participants listened to instrumental music through surround sound speakers. The participants were given ten minutes of screening time prior to performing ICC, and after ICC insertion was complete, the device was withdrawn. The VR device was sanitized before and after each use, and participants were given disposable hygiene covers to prevent the risk of pathogen transmission.
Local anaesthesia will be given as to the participants prior to the procedure at the site of insertion. ICC insertion will be performed by 2 proceduralist with a 3-year experience in performing ICC. Post-procedure, VAS questionnaires will be given to participant (on pain and breathlessness), STAI questionnaire on anxiety and satisfaction questionnaire (Likert's scale). These will be completed by the participants at 30 min post procedure. Vital signs of participant will also be taken and recorded post procedure. The proceduralist will be given satisfaction questionnaire upon completion of procedure
Hypothesis VR leads to better satisfaction of participant during ICC insertion VR reduce pain and anxiety during ICC insertion VR leads to better satisfaction of proceduralist during ICC insertion
Type of Study This is a single center, prospective, interventional study of in-patient participants who are diagnosed with pleural disease and under follow up Respiratory Unit Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia. All participants involved in the study will be randomized by 4 block randomizations into either interventional group (VR) or control group (without VR). All participants will be undergoing small bore ICC drain on top of standard care during procedure.
Demographic data was collected prior to randomization, which included (age, gender, ethnicity, BMI, comorbidities) and indications for ICC. The investigator then randomized into 2 groups via block randomization into intervention (VR) and controlled group (without VR).
Subsequently, consent will be obtained from those who are agree to participate, either from the participant him/herself or their next-of-kin. The process of briefing and obtaining consent will be only done once the participant is stable. These processes will not in any way interfering with clinical evaluation, investigation, treatment and intervention done to the participant by the attending doctor. All of the consented participants will be undergoing ICC insertion.
Prior to the ICC insertion, vital signs will be recorded and both groups will be given a VAS questionnaire to assess their pain and breathlessness. This is done to determine the participant's baseline score pre-procedure. The pain score was measured by the use of validated 10 cm VAS, a 10 cm line anchored with "no pain" at 0 cm and "unbearable pain" at 10 cm. The breathlessness VAS was measured with a similar scale which was anchored with "no breathlessness" at 0 cm, and "worst possible breathlessness" at 10 cm. Participants will also be given State-Trait-Anxiety-Inventory (STAI) questionnaire. It comprised of twenty statements that assess how respondents feel "at the present time.". They were instructed to circle the number that describes the intensity of their feelings concerning each question best: 1, "not at all;" 2, "somewhat;" 3, "moderately so;" 4, "very much so.". The STAI has a potential score range spanning from 20 to 80, and our study employed both English and a verified translated version in Malay for the questionnaire.
After completing the questionnaires, participants in the interventional group will be given the virtual reality (VR) device to wear, which was the Oculus Quest 2 (Oculus, China) before ICC insertion. The device is owned by respiratory unit HCTM and had been utilized in previous study. Videos of natural scenery were played for them while calming instrumental music played in the background. Three-dimensional footage of natural landscapes from across the world was played as participants listened to instrumental music through surround sound speakers. The participants were given ten minutes of screening time prior to performing ICC, and after ICC insertion was complete, the device was withdrawn. The VR device was sanitized before and after each use, and participants were given disposable hygiene covers to prevent the risk of pathogen transmission.
Local anaesthesia will be given as to the participants prior to the procedure at the site of insertion. ICC insertion will be performed by 2 proceduralist with a 3-year experience in performing ICC. Post-procedure, VAS questionnaires will be given to participant (on pain and breathlessness), STAI questionnaire on anxiety and satisfaction questionnaire (Likert's scale). These will be completed by the participants at 30 min post procedure. Vital signs of participant will also be taken and recorded post procedure. The proceduralist will be given satisfaction questionnaire upon completion of procedure
Detailed Description:
Research Questions Can Virtual Reality serve as a diversion and improve participants satisfaction and tolerability during the insertion of a small-bore intercostal chest drain
Hypothesis VR leads to better satisfaction of participant during ICC insertion VR reduce pain and anxiety during ICC insertion VR leads to better satisfaction of proceduralist during ICC insertion
Type of Study This is a single center prospective interventional study of in-patient participants who are diagnosed with pleural disease and under follow up Respiratory Unit Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia All participants involved in the study will be randomized by 4 block randomizations into either interventional group VR or control group without VR All participants will be undergoing small bore ICC drain on top of standard care during procedure
Demographic data was collected prior to randomization which included age gender ethnicity BMI comorbidities and indications for ICC The investigator then randomized into 2 groups via block randomization into intervention VR and controlled group without VR
Subsequently consent will be obtained from those who are agree to participate either from the participant himherself or their next-of-kin The process of briefing and obtaining consent will be only done once the participant is stable These processes will not in any way interfering with clinical evaluation investigation treatment and intervention done to the participant by the attending doctor All of the consented participants will be undergoing ICC insertion
Prior to the ICC insertion vital signs will be recorded and both groups will be given a VAS questionnaire to assess their pain and breathlessness This is done to determine the participants baseline score pre-procedure The pain score was measured by the use of validated 10 cm VAS a 10 cm line anchored with no pain at 0 cm and unbearable pain at 10 cm The breathlessness VAS was measured with a similar scale which was anchored with no breathlessness at 0 cm and worst possible breathlessness at 10 cm Participants will also be given State-Trait-Anxiety-Inventory STAI questionnaire It comprised of twenty statements that assess how respondents feel at the present time They were instructed to circle the number that describes the intensity of their feelings concerning each question best 1 not at all 2 somewhat 3 moderately so 4 very much so The STAI has a potential score range spanning from 20 to 80 and our study employed both English and a verified translated version in Malay for the questionnaire
After completing the questionnaires participants in the interventional group will be given the virtual reality VR device to wear which was the Oculus Quest 2 Oculus China before ICC insertion The device is owned by respiratory unit HCTM and had been utilized in previous study Videos of natural scenery were played for them while calming instrumental music played in the background Three-dimensional footage of natural landscapes from across the world was played as participants listened to instrumental music through surround sound speakers The participants were given ten minutes of screening time prior to performing ICC and after ICC insertion was complete the device was withdrawn The VR device was sanitized before and after each use and participants were given disposable hygiene covers to prevent the risk of pathogen transmission
Local anaesthesia will be given as to the participants prior to the procedure at the site of insertion ICC insertion will be performed by 2 proceduralist with a 3-year experience in performing ICC Post-procedure VAS questionnaires will be given to participant on pain and breathlessness STAI questionnaire on anxiety and satisfaction questionnaire Likerts scale These will be completed by the participants at 30 min post procedure Vital signs of participant will also be taken and recorded post procedure The proceduralist will be given satisfaction questionnaire upon completion of procedure
Hypothesis VR leads to better satisfaction of participant during ICC insertion VR reduce pain and anxiety during ICC insertion VR leads to better satisfaction of proceduralist during ICC insertion
Type of Study This is a single center prospective interventional study of in-patient participants who are diagnosed with pleural disease and under follow up Respiratory Unit Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia All participants involved in the study will be randomized by 4 block randomizations into either interventional group VR or control group without VR All participants will be undergoing small bore ICC drain on top of standard care during procedure
Demographic data was collected prior to randomization which included age gender ethnicity BMI comorbidities and indications for ICC The investigator then randomized into 2 groups via block randomization into intervention VR and controlled group without VR
Subsequently consent will be obtained from those who are agree to participate either from the participant himherself or their next-of-kin The process of briefing and obtaining consent will be only done once the participant is stable These processes will not in any way interfering with clinical evaluation investigation treatment and intervention done to the participant by the attending doctor All of the consented participants will be undergoing ICC insertion
Prior to the ICC insertion vital signs will be recorded and both groups will be given a VAS questionnaire to assess their pain and breathlessness This is done to determine the participants baseline score pre-procedure The pain score was measured by the use of validated 10 cm VAS a 10 cm line anchored with no pain at 0 cm and unbearable pain at 10 cm The breathlessness VAS was measured with a similar scale which was anchored with no breathlessness at 0 cm and worst possible breathlessness at 10 cm Participants will also be given State-Trait-Anxiety-Inventory STAI questionnaire It comprised of twenty statements that assess how respondents feel at the present time They were instructed to circle the number that describes the intensity of their feelings concerning each question best 1 not at all 2 somewhat 3 moderately so 4 very much so The STAI has a potential score range spanning from 20 to 80 and our study employed both English and a verified translated version in Malay for the questionnaire
After completing the questionnaires participants in the interventional group will be given the virtual reality VR device to wear which was the Oculus Quest 2 Oculus China before ICC insertion The device is owned by respiratory unit HCTM and had been utilized in previous study Videos of natural scenery were played for them while calming instrumental music played in the background Three-dimensional footage of natural landscapes from across the world was played as participants listened to instrumental music through surround sound speakers The participants were given ten minutes of screening time prior to performing ICC and after ICC insertion was complete the device was withdrawn The VR device was sanitized before and after each use and participants were given disposable hygiene covers to prevent the risk of pathogen transmission
Local anaesthesia will be given as to the participants prior to the procedure at the site of insertion ICC insertion will be performed by 2 proceduralist with a 3-year experience in performing ICC Post-procedure VAS questionnaires will be given to participant on pain and breathlessness STAI questionnaire on anxiety and satisfaction questionnaire Likerts scale These will be completed by the participants at 30 min post procedure Vital signs of participant will also be taken and recorded post procedure The proceduralist will be given satisfaction questionnaire upon completion of procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None