Postoperative PainNCT04176822
Designing Animated Movie for Preoperative Period
A study testing Educational animated movie group and Documentary movie group in people with Postoperative Pain and Fear, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Background: Using visual materials is effective in education to decrease children's pre-operative fear and post-operative pain. Children, especially those aged between 6 and 12 years, are interested in technology. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Fear, Surgery
- What is being tested?
- Educational animated movie group and Documentary movie group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Sep 2017to 12 Mar 2019
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- First surgery
- Daily surgery and uncomplicated surgery
- Agree to participate in the study
- Speaking Turkish
Who cannot join
- Refusal to participate in the study
- A genetic/congenital disease
- A chronic disease
- Second or more surgery
- Not speaking Turkish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Designing an Educational Animated Movie About Preoperative Preparation on Fear and Post-Operative Pain in Children:A Randomized Controlled Trial
Background: Using visual materials is effective in education to decrease children's pre-operative fear and post-operative pain. Children, especially those aged between 6 and 12 years, are interested in technology. This study aims to investigate the effects of watching an educational animated movie in the pre-operative period on fear and postoperative pain in children who are having surgery.
Methods: The study was a prospective randomized controlled trial. This study was conducted between 6- to 12-year-old children in the Pediatric Surgery Clinic of Ege University Medical Faculty Hospital. The current study includes data from 132 children who were chosen doing block randomization. The "Child and Family Identification Data Form", "Children's Fear Scale" and "Wong-Baker FACES Pain Rating Scale" was used in data collection. The patients were divided randomly into three groups as the "Educational Animated Movie Group" (EAMG), "Documentary Movie Group" (DMG) and "Control Group" (CG). The Educational Animated Movie and Documentary Movie were screened using Virtual Reality (VR). Data were collected by the researcher in the pre-operative period. The pre-operative fear of the child was evaluated by the child and the parent, and the post-operative pain of the child was evaluated by the child, parent, and nurse using scales about fear and pain.
- Conditions
- Postoperative Pain, Fear, Surgery, Pain, Nursing Caries, Nurse's Role
- Being tested
- Educational animated movie group, Documentary movie group
- Keywords
- pediatric surgery, preoperative preparation, animation, fear, pain, nursing
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational animated movie groupOther
Watching educational animation movie which were designed by the researcher before operation for fear and pain.
Documentary movie groupOther
Watching documentary movie about trees before operation for fear and pain.
| Study group | Role | What they receive |
|---|---|---|
| Educational Animated Movie Group | Experimental | All of the children's and parents' written and verbal informed consent were obtained before the study. Parents who did not want to participate in the study were assured that this would not have any adverse effect on their child's treatment. In the morning of surgery, the researcher administered the "Child and Family Identification Data Form" to the parents of children who had the following parameters. Later, both the child and the parents were asked to complete the "Children's Fear Scale". Children included in the study groups with randomization watched an educational animated movie through VR Goggles. The educational animated movie lasted around 3-4 minutes each. After watching the movie, children and parents were asked to complete the Children's Fear Scale again. Children, parents, and nurses were asked to grade the pain of the child with Wong-Baker FACES Pain Rating Scale when the children returned to their room and after 1 hour in the postoperative period. Receives: Other: Educational animated movie group |
| Documentary Movie Group | Experimental | All of the children's and parents' written and verbal informed consent were obtained before the study. Parents who did not want to participate in the study were assured that this would not have any adverse effect on their child's treatment. In the morning of surgery, the researcher administered the "Child and Family Identification Data Form" to the parents of children who had the following parameters. Later, both the child and the parents were asked to complete the "Children's Fear Scale". Children included in the study groups with randomization watched a documentary movie through VR Goggles. The documentary movie lasted around 3-4 minutes each. After watching the movie, children and parents were asked to complete the Children's Fear Scale again. Children, parents, and nurses were asked to grade the pain of the child with Wong-Baker FACES Pain Rating Scale when the children returned to their room and after 1 hour in the postoperative period. Receives: Other: Documentary movie group |
| Control Group | No intervention | No intervention was made, pain and fear levels were measured using scales only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Children's Preoperative Fear
"Children's Fear Scale" (CFS) was developed and adapted by McMurtry et al. (2011).
This scale includes 5 different facial expressions. This scale, graded between 0 and 4, ("0" is none fear, "4" is maximum fear) is a reliable and valid measurement tool for assessing fear.
It includes measuring and evaluating preoperative fears of children.
Measured: 15 minutes (2 measurements are made-before and after intervention)
Change of Children's Postopeartive Pain
"Wong-Baker FACES Pain Rating Scale" This scale includes six different facial expressions and is scored between 0 and 10 ("0" is none pain, "10" is maximum pain). It is a reliable and valid measurement tool for acute pain assessment, and it does not require words or numeric value.
It includes measuring and evaluating postoperative pains of children.
Measured: 15 minutes (2 measurements are made-immediately after surgery and 1 hour after surgery) = total 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start4 Sep 2017
- Primary completion28 Sep 2018
- Study completion12 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Ege 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- There are 3 independent working groups.
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeyda BİNAY YAZ, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176822
- Sponsor's protocol ID
- SYaz
- Other IDs
- Ege
- Status last verified
- Nov 2019
- First submitted
- 1 Nov 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study will be prepared for publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Designing an Educational Animated Movie About Preoperative Preparation on Fear and Post-Operative Pain in Children:A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04176822
- Acronym / sponsor ID
- SYaz
- Conditions
- Postoperative Pain, Fear, Surgery, Pain, Nursing Caries, Nurse's Role
- Keywords
- pediatric surgery, preoperative preparation, animation, fear, pain, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 28 Sep 2018 (actual)
- Study completion
- 12 Mar 2019 (actual)
- First posted
- 25 Nov 2019 (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.
Background: Using visual materials is effective in education to decrease children's pre-operative fear and post-operative pain. Children, especially those aged between 6 and 12 years, are interested in technology. This study aims to investigate the effects of watching an educational animated movie in the pre-operative period on fear and postoperative pain in children who are having surgery.
Methods: The study was a prospective randomized controlled trial. This study was conducted between 6- to 12-year-old children in the Pediatric Surgery Clinic of Ege University Medical Faculty Hospital. The current study includes data from 132 children who were chosen doing block randomization. The "Child and Family Identification Data Form", "Children's Fear Scale" and "Wong-Baker FACES Pain Rating Scale" was used in data collection. The patients were divided randomly into three groups as the "Educational Animated Movie Group" (EAMG), "Documentary Movie Group" (DMG) and "Control Group" (CG). The Educational Animated Movie and Documentary Movie were screened using Virtual Reality (VR). Data were collected by the researcher in the pre-operative period. The pre-operative fear of the child was evaluated by the child and the parent, and the post-operative pain of the child was evaluated by the child, parent, and nurse using scales about fear and pain.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- There are 3 independent working groups.
| Arm | Type | Receives |
|---|---|---|
| Educational Animated Movie Group | Experimental | Other: Educational animated movie groupAll of the children's and parents' written and verbal informed consent were obtained before the study. Parents who did not want to participate in the study were assured that this would not have any adverse effect on their child's treatment. In the morning of surgery, the researcher administered the "Child and Family Identification Data Form" to the parents of children who had the following parameters. Later, both the child and the parents were asked to complete the "Children's Fear Scale". Children included in the study groups with randomization watched an educational animated movie through VR Goggles. The educational animated movie lasted around 3-4 minutes each. After watching the movie, children and parents were asked to complete the Children's Fear Scale again. Children, parents, and nurses were asked to grade the pain of the child with Wong-Baker FACES Pain Rating Scale when the children returned to their room and after 1 hour in the postoperative period. |
| Documentary Movie Group | Experimental | Other: Documentary movie groupAll of the children's and parents' written and verbal informed consent were obtained before the study. Parents who did not want to participate in the study were assured that this would not have any adverse effect on their child's treatment. In the morning of surgery, the researcher administered the "Child and Family Identification Data Form" to the parents of children who had the following parameters. Later, both the child and the parents were asked to complete the "Children's Fear Scale". Children included in the study groups with randomization watched a documentary movie through VR Goggles. The documentary movie lasted around 3-4 minutes each. After watching the movie, children and parents were asked to complete the Children's Fear Scale again. Children, parents, and nurses were asked to grade the pain of the child with Wong-Baker FACES Pain Rating Scale when the children returned to their room and after 1 hour in the postoperative period. |
| Control Group | No intervention | –No intervention was made, pain and fear levels were measured using scales only. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- First surgery
- Daily surgery and uncomplicated surgery
- Agree to participate in the study
- Speaking Turkish
Key exclusion criteria (5 listed)
- Refusal to participate in the study
- A genetic/congenital disease
- A chronic disease
- Second or more surgery
- Not speaking Turkish
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 |
|---|---|---|
| Educational animated movie groupWatching educational animation movie which were designed by the researcher before operation for fear and pain. | Other | Educational Animated Movie Group |
| Documentary movie groupWatching documentary movie about trees before operation for fear and pain. | Other | Documentary Movie Group |
Primary outcome
Change of Children's Preoperative Fear
Time frame: 15 minutes (2 measurements are made-before and after intervention)
"Children's Fear Scale" (CFS) was developed and adapted by McMurtry et al. (2011). This scale includes 5 different facial expressions. This scale, graded between 0 and 4, ("0" is none fear, "4" is maximum fear) is a reliable and valid measurement tool for assessing fear. It includes measuring and evaluating preoperative fears of children.
Change of Children's Postopeartive Pain
Time frame: 15 minutes (2 measurements are made-immediately after surgery and 1 hour after surgery) = total 90 minutes
"Wong-Baker FACES Pain Rating Scale" This scale includes six different facial expressions and is scored between 0 and 10 ("0" is none pain, "10" is maximum pain). It is a reliable and valid measurement tool for acute pain assessment, and it does not require words or numeric value. It includes measuring and evaluating postoperative pains of children.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Individual participant dataSharing planned: No. The study will be prepared for publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational animated movie group and Documentary movie group in people with Postoperative Pain and Fear, run by Ege 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 5 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: finished, as of the sponsor's last update on 26 Nov 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Children's Preoperative Fear (time frame: 15 minutes (2 measurements are made-before and after intervention)). 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?
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 26 Nov 2019.