AnxietyNCT05186766
The Effect of Video-Assisted Operating Room Introduce Program (VIASP-OR)
A study testing Video-Assisted Operating Room Introduce Program in people with Anxiety and Parent-Child Relations, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Aim: The aim of this study is to evaluate the effect of the video-assisted operating room promotion program developed for parents on the anxiety level of parents and children. Design: Randomized controlled trial. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Parent-Child Relations
- What is being tested?
- Video-Assisted Operating Room Introduce Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents of children aged 7-12
- Parents whose child will undergo surgery for the first time
- Parents of children who will undergo elective surgery
- Parents who can speak Turkish, understand what they read and listen to, and can apply what is said will be included.
Who cannot join
- Parents with previous surgical experience
- Parents who used psychiatric drugs
- Parents with a child receiving sedative premedication
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University
Antalya, 07070
Cafer Özdemir, +905069665581, cozdemir@akdeniz.edu.tr
Cafer OZDEMİR
About this study
Official title: The Effect of Video-Assisted Operating Room Introduce Program (VIASP-OR) Developed for Parents on Parental and Child Anxiety: Randomized Controlled Study Protocol
Aim: The aim of this study is to evaluate the effect of the video-assisted operating room promotion program developed for parents on the anxiety level of parents and children.
Design: Randomized controlled trial. Methods: The participants (N = 80) will be randomly assigned (1:1) to the intervention and control groups using block randomization. In addition to standard care, a video-assisted operating room promotion program, created by fully addressing the perioperative process, will be applied to the participants assigned to the intervention group. Participants in the control group will only receive standard care. Standard care includes verbal information about the surgical process. The sociodemographic and clinical characteristics, along with the anxiety levels of the children and their parents were measured one day before the operation, and the anxiety levels were again measured on the postoperative first and second day.
Read more
Discussion: In the literature, it is seen that pediatric surgery personnel can have a beneficial effect in reducing the anxiety of children and their parents. Among these methods, the effectiveness of distraction methods on children's anxiety has also been proven. As for parental anxiety, which can be as important as child anxiety, not enough studies have been done so far, and the existing studies have not been able to come to a decisive conclusion. If parental intervention is found to have positive effects on the child's anxiety in this study are positive, it will contribute to clinical practice and improve clinical outcomes. In this respect, it will fill this gap in the literature.
Impact: This research will add to the evidence for the effectiveness of an intervention that provides parents with visual and auditory information about the process prior to child surgery. It will benefit parents who want to support their children in managing this process. It will also support nurses working in pediatric surgery clinics.
Trial registration: It was registered at ClinicalTrials.gov in December 2021 (…………).
Read the detailed description
It is a fact that an advanced care process that can provide the necessary support to the parents is needed to reduce the anxiety levels before the surgery. Preparation for surgery for the child and family should focus on their unique needs and include a holistic approach to the child's physical and psychological preparation. For this reason, there is a need for studies that include a holistic approach to managing child and parent anxiety together in line with the family-centered care philosophy. There are different interventions applied to reduce child and parent anxiety in the preoperative process. Examples of these interventions are simply explaining complex information to parents by visualizing data via a tablet computer, clown intervention, distraction through music, humor, therapeutic play, and audio-visual methods. Introducing the real operating room environment, which is full of unknowns and other than traditional education methods, with video can have a positive effect on reducing the anxiety of parents and children. For this reason, we think that such a study will make a positive contribution to the literature.
- Conditions
- Anxiety, Parent-Child Relations
- Being tested
- Video-Assisted Operating Room Introduce Program
- Keywords
- Children, Parents, Anxiety, Technology, Video, Surgery
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Assisted Operating Room Introduce ProgramDevice
Also called VIASP-OR
Video demonstration about operation room
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Video-Assisted Operating Room Introduce Program (VIASP-OR) Receives: Device: Video-Assisted Operating Room Introduce Program |
| Control Group | No intervention | Standart Nursing Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent Anxiety-
The State Anxiety Inventory (STAI-S) The scores obtained from this scale range from a minimum of 20 to a maximum of 80. High score means high anxiety level and low score means low anxiety level.
Measured: First day before operation
Parent Anxiety
The State Anxiety Inventory (STAI-S) The scores obtained from this scale range from a minimum of 20 to a maximum of 80. High score means high anxiety level and low score means low anxiety level.
Measured: First day after operation
Parent Anxiety
The State Anxiety Inventory (STAI-S) The scores obtained from this scale range from a minimum of 20 to a maximum of 80. High score means high anxiety level and low score means low anxiety level.
Measured: Second day after operation
Secondary outcomes (3)
Child anxiety
Facial Affective Scale (FAS) The FAS used for children consists of 5 facial expressions. In expressions ranging from 1 to 5, the first facial expression indicates no anxiety, and the fifth facial expression indicates a very high level of anxiety.
Measured: First day before operation
Child anxiety
Facial Affective Scale (FAS) The FAS used for children consists of 5 facial expressions. In expressions ranging from 1 to 5, the first facial expression indicates no anxiety, and the fifth facial expression indicates a very high level of anxiety.
Measured: First day after operation
Child anxiety
Facial Affective Scale (FAS) The FAS used for children consists of 5 facial expressions. In expressions ranging from 1 to 5, the first facial expression indicates no anxiety, and the fifth facial expression indicates a very high level of anxiety.
Measured: Second day after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Feb 2022 (estimated)
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cafer Özdemir, Akdeniz University
- Investigators
- Ebru KARAZEYBEK, Study director, Akdeniz University Faculty of NursingAysegul ISLER DALGIC, Study director, Akdeniz University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186766
- Sponsor's protocol ID
- KAEK-741
- Status last verified
- Jan 2022
- First submitted
- 9 Dec 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozdemir C, Duzgun MV, Karazeybek E, Isler Dalgic A. The effect of a video-assisted operating room promotion program on the anxiety levels of parents and their children: A randomized controlled trial protocol. J Pediatr Nurs. 2022 Nov-Dec;67:e150-e155. doi: 10.1016/j.pedn.2022.08.006. Epub 2022 Aug 19.
PubMed 35995689
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Video-Assisted Operating Room Introduce Program (VIASP-OR) Developed for Parents on Parental and Child Anxiety: Randomized Controlled Study Protocol
- ClinicalTrials.gov ID
- NCT05186766
- Acronym / sponsor ID
- KAEK-741
- Conditions
- Anxiety, Parent-Child Relations
- Keywords
- Children, Parents, Anxiety, Technology, Video, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 11 Jan 2022 (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.
Aim: The aim of this study is to evaluate the effect of the video-assisted operating room promotion program developed for parents on the anxiety level of parents and children.
Design: Randomized controlled trial. Methods: The participants (N = 80) will be randomly assigned (1:1) to the intervention and control groups using block randomization. In addition to standard care, a video-assisted operating room promotion program, created by fully addressing the perioperative process, will be applied to the participants assigned to the intervention group. Participants in the control group will only receive standard care. Standard care includes verbal information about the surgical process. The sociodemographic and clinical characteristics, along with the anxiety levels of the children and their parents were measured one day before the operation, and the anxiety levels were again measured on the postoperative first and second day.
Discussion: In the literature, it is seen that pediatric surgery personnel can have a beneficial effect in reducing the anxiety of children and their parents. Among these methods, the effectiveness of distraction methods on children's anxiety has also been proven. As for parental anxiety, which can be as important as child anxiety, not enough studies have been done so far, and the existing studies have not been able to come to a decisive conclusion. If parental intervention is found to have positive effects on the child's anxiety in this study are positive, it will contribute to clinical practice and improve clinical outcomes. In this respect, it will fill this gap in the literature.
Impact: This research will add to the evidence for the effectiveness of an intervention that provides parents with visual and auditory information about the process prior to child surgery. It will benefit parents who want to support their children in managing this process. It will also support nurses working in pediatric surgery clinics.
Trial registration: It was registered at ClinicalTrials.gov in December 2021 (…………).
Detailed description
It is a fact that an advanced care process that can provide the necessary support to the parents is needed to reduce the anxiety levels before the surgery. Preparation for surgery for the child and family should focus on their unique needs and include a holistic approach to the child's physical and psychological preparation. For this reason, there is a need for studies that include a holistic approach to managing child and parent anxiety together in line with the family-centered care philosophy. There are different interventions applied to reduce child and parent anxiety in the preoperative process. Examples of these interventions are simply explaining complex information to parents by visualizing data via a tablet computer, clown intervention, distraction through music, humor, therapeutic play, and audio-visual methods. Introducing the real operating room environment, which is full of unknowns and other than traditional education methods, with video can have a positive effect on reducing the anxiety of parents and children. For this reason, we think that such a study will make a positive contribution to the literature.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Video-Assisted Operating Room Introduce ProgramVideo-Assisted Operating Room Introduce Program (VIASP-OR) |
| Control Group | No intervention | –Standart Nursing Care |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Parents of children aged 7-12
- Parents whose child will undergo surgery for the first time
- Parents of children who will undergo elective surgery
- Parents who can speak Turkish, understand what they read and listen to, and can apply what is said will be included.
Key exclusion criteria (3 listed)
- Parents with previous surgical experience
- Parents who used psychiatric drugs
- Parents with a child receiving sedative premedication
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 |
|---|---|---|
| Video-Assisted Operating Room Introduce ProgramAlso: VIASP-ORVideo demonstration about operation room | Device | Intervention Group |
Primary outcome
Parent Anxiety-
Time frame: First day before operation
The State Anxiety Inventory (STAI-S) The scores obtained from this scale range from a minimum of 20 to a maximum of 80. High score means high anxiety level and low score means low anxiety level.
Parent Anxiety
Time frame: First day after operation
The State Anxiety Inventory (STAI-S) The scores obtained from this scale range from a minimum of 20 to a maximum of 80. High score means high anxiety level and low score means low anxiety level.
Parent Anxiety
Time frame: Second day after operation
The State Anxiety Inventory (STAI-S) The scores obtained from this scale range from a minimum of 20 to a maximum of 80. High score means high anxiety level and low score means low anxiety level.
3 secondary outcomes
Child anxiety
Time frame: First day before operation
Child anxiety
Time frame: First day after operation
Child anxiety
Time frame: Second day after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Derived from this study: PubMed 35995689Ozdemir C, Duzgun MV, Karazeybek E, Isler Dalgic A. The effect of a video-assisted operating room promotion program on the anxiety levels of parents and their children: A randomized controlled trial protocol. J Pediatr Nurs. 2022 Nov-Dec;67:e150-e155. doi: 10.1016/j.pedn.2022.08.006. Epub 2022 Aug 19.
- 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. This study is not recruiting at the moment.
Ebru KARAZEYBEK study director
Akdeniz University Faculty of Nursing
Aysegul ISLER DALGIC study director
Akdeniz University Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-Assisted Operating Room Introduce Program in people with Anxiety and Parent-Child Relations, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Feb 2022. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cafer Özdemir (05069665581, cozdemir@akdeniz.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Anxiety- (time frame: First day before operation). The study lists 3 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 NCT05186766, which also lists 1 linked publication.
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 1 Feb 2022.