AnxietyNCT04976114
Reducing Preoperative Anxiety in Parents of Surgical Patients
A study testing Story book with information about surgery techniques, Video with information about surgery techniques and Story book and Video with information about surgery techniques in people with Anxiety, run by Hospital San Carlos, Madrid.
Trial summary
Aims and objectives: To investigate preoperative anxiety in parents of paediatric surgical patients, testing whether the provision of information (using video and story books) regarding the surgical process can impact on reducing anxiety. Analyse if some personal factors influence the reduction of anxiety. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Story book with information about surgery techniques, Video with information about surgery techniques and Story book and Video with information about surgery techniques
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 1 Oct 2017
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Undergoing surgery at Asturias Central Hospital
Who cannot join
- Children not in the age range,
- Emergency surgery,
- Children not able to understand or read
- Parents not present or refused to participate.
About this study
Aims and objectives: To investigate preoperative anxiety in parents of paediatric surgical patients, testing whether the provision of information (using video and story books) regarding the surgical process can impact on reducing anxiety. Analyse if some personal factors influence the reduction of anxiety.
Background: Attending a surgical theatre generates anxiety in all types of patients, especially in the case of children. The effect of different preoperative intervention procedures in children that attempt to reduce their anxiety level have been studied a great deal. However, although their parents also suffer high anxiety levels, potential intervention to reduce their levels have not received the same attention.
Study design: Randomised Clinical trial Methods: One hundred and twenty-five parents of children (8-12 y.o.) undergoing surgery in Hospital Universitario Central de Asturias hospital (Oviedo, Spain) were randomly assigned to the control group (34 individuals) or one of the 3 experimental groups (91). After the pre-anaesthesia consultation, children and parents of the experimental groups were provided with a story book, a video with additional information of nursing, or both. In the antechamber of the operating room and prior to the surgical intervention, the State Anxiety and Trait Anxiety of the parents and children were measured using the STAI and STAIC questionnaires respectively. The data collection, including different demographic variables was carried out for 12 months starting in October 2016
- Conditions
- Anxiety
- Being tested
- Story book with information about surgery techniques, Video with information about surgery techniques, Story book and Video with information about surgery techniques
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Story book with information about surgery techniquesProcedure or surgery
Presurgery use of Story book. The parents with the child read a book with information about surgery techniques the days before surgery.
Video with information about surgery techniquesProcedure or surgery
Presurgery use of video. The parents with the child watch a video with information about surgery techniques the days before surgery.
Story book and Video with information about surgery techniquesProcedure or surgery
Presurgery use of video and story book. The parents with the child watch a video and read a book (both) with information about surgery techniques the days before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Standard of care |
| story book | Experimental | Parents read a book with the chid previous to surgery. Receives: Procedure: Story book with information about surgery techniques |
| video | Experimental | Parents watch a video with the chid previous to surgery. Receives: Procedure: Video with information about surgery techniques |
| both instrument | Experimental | Parents read a book and watch a video with the chid previous to surgery. Receives: Procedure: Story book and Video with information about surgery techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level
Level of presurgery anxiety measured by State-Trait Anxiety Inventory scale
Measured: Presurgery, just the moment before to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start1 Oct 2016
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomised and blind clinical trial. The parents could be randomly assigned to the control group, and received the standard procedure, or to the experimental groups. Three experimental groups were possible regarding the various types of interventions: story book (IG1), video (IG2), or both instruments (IG3)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilio Vargas Castrillón, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976114
- Sponsor's protocol ID
- preoperative anxiety
- Status last verified
- Jul 2021
- First submitted
- 9 Jul 2021
- Last updated
- 26 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results will be able after request with considerable reasons
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Preoperative Anxiety in Parents of Surgical Patients
- ClinicalTrials.gov ID
- NCT04976114
- Acronym / sponsor ID
- preoperative anxiety
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 26 Jul 2021 (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.
Aims and objectives: To investigate preoperative anxiety in parents of paediatric surgical patients, testing whether the provision of information (using video and story books) regarding the surgical process can impact on reducing anxiety. Analyse if some personal factors influence the reduction of anxiety.
Background: Attending a surgical theatre generates anxiety in all types of patients, especially in the case of children. The effect of different preoperative intervention procedures in children that attempt to reduce their anxiety level have been studied a great deal. However, although their parents also suffer high anxiety levels, potential intervention to reduce their levels have not received the same attention.
Study design: Randomised Clinical trial Methods: One hundred and twenty-five parents of children (8-12 y.o.) undergoing surgery in Hospital Universitario Central de Asturias hospital (Oviedo, Spain) were randomly assigned to the control group (34 individuals) or one of the 3 experimental groups (91). After the pre-anaesthesia consultation, children and parents of the experimental groups were provided with a story book, a video with additional information of nursing, or both. In the antechamber of the operating room and prior to the surgical intervention, the State Anxiety and Trait Anxiety of the parents and children were measured using the STAI and STAIC questionnaires respectively. The data collection, including different demographic variables was carried out for 12 months starting in October 2016
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- A randomised and blind clinical trial. The parents could be randomly assigned to the control group, and received the standard procedure, or to the experimental groups. Three experimental groups were possible regarding the various types of interventions: story book (IG1), video (IG2), or both instruments (IG3)
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Standard of care |
| story book | Experimental | Procedure: Story book with information about surgery techniquesParents read a book with the chid previous to surgery. |
| video | Experimental | Procedure: Video with information about surgery techniquesParents watch a video with the chid previous to surgery. |
| both instrument | Experimental | Procedure: Story book and Video with information about surgery techniquesParents read a book and watch a video with the chid previous to surgery. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Undergoing surgery at Asturias Central Hospital
Key exclusion criteria (4 listed)
- Children not in the age range,
- Emergency surgery,
- Children not able to understand or read
- Parents not present or refused to participate.
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 |
|---|---|---|
| Story book with information about surgery techniquesPresurgery use of Story book. The parents with the child read a book with information about surgery techniques the days before surgery. | Procedure or surgery | story book |
| Video with information about surgery techniquesPresurgery use of video. The parents with the child watch a video with information about surgery techniques the days before surgery. | Procedure or surgery | video |
| Story book and Video with information about surgery techniquesPresurgery use of video and story book. The parents with the child watch a video and read a book (both) with information about surgery techniques the days before surgery. | Procedure or surgery | both instrument |
Primary outcome
Anxiety level
Time frame: Presurgery, just the moment before to surgery
Level of presurgery anxiety measured by State-Trait Anxiety Inventory scale
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 Jul 2021.
- Individual participant dataSharing planned: No. The results will be able after request with considerable reasons
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Story book with information about surgery techniques, Video with information about surgery techniques and Story book and Video with information about surgery techniques in people with Anxiety, run by Hospital San Carlos, Madrid.
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 1 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: finished, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Anxiety level (time frame: Presurgery, just the moment before to surgery). 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 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.