Major TraumaNCT04551157
Impact of Psychoeducational Video on Adjustment to Open Fracture.
A study testing Video Viewing in people with Major Trauma, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
The multi-disciplinary team involved in the care of major trauma patients with open fractures has developed two novel patient information videos. They include practical advice from staff about the recovery process, images of the wound throughout the healing process and ways to cope with the range of emotional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Trauma
- What is being tested?
- Video Viewing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Dec 2020to 1 Nov 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Fluent in English.
- Diagnosed with an open fracture.
- Inpatient stay of >72 hours.
Who cannot join
- Participant has a diagnosis of dementia.
- Participant is experiencing delirium.
- Participant has a complete spinal fracture.
- Participant has a traumatic brain injury with a clinically significant presentation.
- Participant is unable to provide written consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: Early Adjustment Following Open Fracture: the Impact of Viewing Psychoeducational Video Material.
The multi-disciplinary team involved in the care of major trauma patients with open fractures has developed two novel patient information videos. They include practical advice from staff about the recovery process, images of the wound throughout the healing process and ways to cope with the range of emotional responses that patients report following an open fracture. The experiences of previous patients are also included. The aim of this project is to evaluate the impact of viewing these videos on patients' ability to follow treatment recommendations made by the team, as well as their psychological and social functioning, as measured by standardised questionnaire responses. Additionally, the patient's experience of viewing the videos, in terms of how relevant and useful they found them, will be evaluated.
Read the detailed description
High levels of psychological difficulty are often reported by patients with an open fracture. These patients frequently describe feeling distressed by the initial appearance of their scars and can struggle to adjust and prepare for the challenges they face on discharge from hospital. Patients' expectations about the appearance of their wounds and their role in the recovery process may be aided with access to visual material that the patient and their family can revisit as often as is helpful to them.
Therefore, the multi-disciplinary team involved in the care of these patients has developed two novel patient information videos. They include practical advice from staff about the recovery process, images of the wound throughout the healing process and ways to cope with the range of emotional responses that patients report following an open fracture. The experiences of previous patients are also included. The aim of this project is to evaluate the impact of viewing these videos on patients' ability to follow treatment recommendations made by the team, as well as their psychological and social functioning, as measured by standardised questionnaire responses. Additionally, the patient's experience of viewing the videos, in terms of how relevant and useful they found them, will be evaluated.
All adult patients with an open fracture attending the John Radcliffe Hospital Major Trauma Centre will be eligible to take part (unless they have a diagnosis of dementia, active delirium or traumatic brain injury). Participation will involve completing questionnaires whilst in hospital (within the first week and prior to discharge) and at a routine 3-month follow-up appointment. Patients will be randomly selected to either view the videos or receive treatment as usual. The questionnaire responses of patients in these two groups will be compared to help evaluate the videos.
- Conditions
- Major Trauma
- Being tested
- Video Viewing
- Keywords
- major trauma, open fracture, intervention, appearance
- Medical subject headings
- Fractures, Open
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video ViewingOther
Two patient information videos containing practical advice from staff about the recovery process, images of the wound throughout the healing process and ways to cope with the range of emotional responses that patients report following an open fracture.
| Study group | Role | What they receive |
|---|---|---|
| Video Viewing | Experimental | Participants will receive the intervention where they will view two patient information videos. The first video will be viewed within the first week of their inpatient stay and the second video will be viewed just before discharge. Receives: Other: Video Viewing |
| Treatment as usual | No intervention | No change to routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcomes Routine Evaluation 10 (CORE-10)
The CORE-10 is a brief, generic and easy-to-use measure of psychological distress. It is a self-report questionnaire with ten items about how the respondent has been feeling over the last week, with a 5-point Likert scale (Not at all/Only occasionally/Sometimes/Often/Most of the time). These items cover symptoms (depression, anxiety, trauma, physical problems), functioning (general, social and close relationships sub-domains) and risk to self. All items are summed (items 2 and 3 are reversed scored). The minimum score is 0 and the maximum score is 40, with higher scores indicating higher levels of psychological distress. The clinical cut-off score for general psychological distress is 11.0. The clinical cut-off for depression is 13.0 (sensitivity and specificity values of .92 and 0.72 respectively).
Measured: 3-7 days after hospital admission (Timepoint 1 - baseline)
Clinical Outcomes Routine Evaluation 10 (CORE-10)
The CORE-10 is a brief, generic and easy-to-use measure of psychological distress. It is a self-report questionnaire with ten items about how the respondent has been feeling over the last week, with a 5-point Likert scale (Not at all/Only occasionally/Sometimes/Often/Most of the time). These items cover symptoms (depression, anxiety, trauma, physical problems), functioning (general, social and close relationships sub-domains) and risk to self. All items are summed (items 2 and 3 are reversed scored). The minimum score is 0 and the maximum score is 40, with higher scores indicating higher levels of psychological distress. The clinical cut-off score for general psychological distress is 11.0. The clinical cut-off for depression is 13.0 (sensitivity and specificity values of .92 and 0.72 respectively).
Measured: 7-14 days after admission (Timepoint 2 - prior to discharge)
Clinical Outcomes Routine Evaluation 10 (CORE-10)
The CORE-10 is a brief, generic and easy-to-use measure of psychological distress. It is a self-report questionnaire with ten items about how the respondent has been feeling over the last week, with a 5-point Likert scale (Not at all/Only occasionally/Sometimes/Often/Most of the time). These items cover symptoms (depression, anxiety, trauma, physical problems), functioning (general, social and close relationships sub-domains) and risk to self. All items are summed (items 2 and 3 are reversed scored). The minimum score is 0 and the maximum score is 40, with higher scores indicating higher levels of psychological distress. The clinical cut-off score for general psychological distress is 11.0. The clinical cut-off for depression is 13.0 (sensitivity and specificity values of .92 and 0.72 respectively).
Measured: 3-months post-injury (Timepoint 3 - follow-up)
Appearance-Related Psychosocial Distress Scale
This is an 8-item self-report scale where respondents are asked to disagree or agree to 8 statements about their appearance using a 4-point likert scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). The minimum score is 8 and the maximum is 32, which higher scores indicating higher levels of appearance-related psychosocial distress. Klassen and colleagues (2016) used Rasch Measurement Theory (RMT) analysis to assess the psychometric properties of the measure. Person Separation Index (analogous to a reliability index) and Cronbach alpha values were 0.81 and 0.89 respectively. Convergent and predictive validity of this scale have not yet been assessed.
Measured: 3-7 days after hospital admission (Timepoint 1 - baseline)
Appearance-Related Psychosocial Distress Scale
This is an 8-item self-report scale where respondents are asked to disagree or agree to 8 statements about their appearance using a 4-point likert scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). The minimum score is 8 and the maximum is 32, which higher scores indicating higher levels of appearance-related psychosocial distress. Klassen and colleagues (2016) used Rasch Measurement Theory (RMT) analysis to assess the psychometric properties of the measure. Person Separation Index (analogous to a reliability index) and Cronbach alpha values were 0.81 and 0.89 respectively. Convergent and predictive validity of this scale have not yet been assessed.
Measured: 7-14 days after admission (Timepoint 2 - prior to discharge)
Appearance-Related Psychosocial Distress Scale
This is an 8-item self-report scale where respondents are asked to disagree or agree to 8 statements about their appearance using a 4-point likert scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). The minimum score is 8 and the maximum is 32, which higher scores indicating higher levels of appearance-related psychosocial distress. Klassen and colleagues (2016) used Rasch Measurement Theory (RMT) analysis to assess the psychometric properties of the measure. Person Separation Index (analogous to a reliability index) and Cronbach alpha values were 0.81 and 0.89 respectively. Convergent and predictive validity of this scale have not yet been assessed.
Measured: 3-months post-injury (Timepoint 3 - follow-up)
Trauma Screening Questionnaire (TSQ)
The TSQ is a 10-item self-report questionnaire with items covering the different reactions that sometimes occur after a traumatic event. Respondents are asked to endorse Yes/No to whether or not they have experienced any of the following at least twice in the last week. Predictive validity of respondents who endorsed at least six of the re-experiencing or arousal items (in any combination) was excellent. Sensitivity was 0.86 and specificity was 0.93. Other research by Brewin, Fuchkan, Huntley \& Scragg (2010) has indicated low specificity in non-white samples. Specificity was also low if the TSQ was administered early after the trauma but this improved in the eighteen months following the event.
Measured: 3-7 days after hospital admission (Timepoint 1 - baseline)
Trauma Screening Questionnaire (TSQ)
The TSQ is a 10-item self-report questionnaire with items covering the different reactions that sometimes occur after a traumatic event. Respondents are asked to endorse Yes/No to whether or not they have experienced any of the following at least twice in the last week. Predictive validity of respondents who endorsed at least six of the re-experiencing or arousal items (in any combination) was excellent. Sensitivity was 0.86 and specificity was 0.93. Other research by Brewin, Fuchkan, Huntley \& Scragg (2010) has indicated low specificity in non-white samples. Specificity was also low if the TSQ was administered early after the trauma but this improved in the eighteen months following the event.
Measured: 7-14 days after admission (Timepoint 2 - prior to discharge)
Trauma Screening Questionnaire (TSQ)
The TSQ is a 10-item self-report questionnaire with items covering the different reactions that sometimes occur after a traumatic event. Respondents are asked to endorse Yes/No to whether or not they have experienced any of the following at least twice in the last week. Predictive validity of respondents who endorsed at least six of the re-experiencing or arousal items (in any combination) was excellent. Sensitivity was 0.86 and specificity was 0.93. Other research by Brewin, Fuchkan, Huntley \& Scragg (2010) has indicated low specificity in non-white samples. Specificity was also low if the TSQ was administered early after the trauma but this improved in the eighteen months following the event.
Measured: 3-months post-injury (Timepoint 3 - follow-up)
General Adherence Measure
This is a general measure of patient's adherence to treatment, where respondents are asked how often they were able to adhere to their treatment. It has 5-items and a 6-point Likert response scale (None of the time/A little of the time/Some of the time/A good bit of the time/Most of the time/All of the time). The minimum score is 5 and the maximum score is 24, with higher scores indicating better adherence to treatment. The internal consistency of the measure has been found to be acceptable with a Cronbach's alpha of 0.81 (Hays, n.d).
Measured: 3-7 days after hospital admission (Timepoint 1 - baseline)
General Adherence Measure
This is a general measure of patient's adherence to treatment, where respondents are asked how often they were able to adhere to their treatment. It has 5-items and a 6-point Likert response scale (None of the time/A little of the time/Some of the time/A good bit of the time/Most of the time/All of the time). The minimum score is 5 and the maximum score is 24, with higher scores indicating better adherence to treatment. The internal consistency of the measure has been found to be acceptable with a Cronbach's alpha of 0.81 (Hays, n.d).
Measured: 7-14 days after admission (Timepoint 2 - prior to discharge)
General Adherence Measure
This is a general measure of patient's adherence to treatment, where respondents are asked how often they were able to adhere to their treatment. It has 5-items and a 6-point Likert response scale (None of the time/A little of the time/Some of the time/A good bit of the time/Most of the time/All of the time). The minimum score is 5 and the maximum score is 24, with higher scores indicating better adherence to treatment. The internal consistency of the measure has been found to be acceptable with a Cronbach's alpha of 0.81 (Hays, n.d).
Measured: 3-months post-injury (Timepoint 3 - follow-up)
Condition specific statements about treatment and scarring
This includes 4 statements about the patient's treatment and 10 about their scarring, written by the chief investigator and based on clinical experience. The items address how the patient feels about their treatment, their expectations about ongoing treatment and healing and their role in the recovery process. The items focus on the patient's emotional responses to their scars and their perceptions about the impact the scars may have on their quality of life. These items are on a 4-point agreement scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). For the treatment section, the minimum score is 4 and the maximum score is 16, with higher scores indicating better understanding of treatment. and better adjustment/more positive attitudes towards scarring respectively. For the scarring section, the minimum score is 10 and the maximum score is 40, with higher scores indicating better adjustment/more positive attitudes towards scarring respectively.
Measured: 3-7 days after hospital admission (Timepoint 1 - baseline)
Condition specific statements about treatment and scarring
This includes 4 statements about the patient's treatment and 10 about their scarring, written by the chief investigator and based on clinical experience. The items address how the patient feels about their treatment, their expectations about ongoing treatment and healing and their role in the recovery process. The items focus on the patient's emotional responses to their scars and their perceptions about the impact the scars may have on their quality of life. These items are on a 4-point agreement scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). For the treatment section, the minimum score is 4 and the maximum score is 16, with higher scores indicating better understanding of treatment. and better adjustment/more positive attitudes towards scarring respectively. For the scarring section, the minimum score is 10 and the maximum score is 40, with higher scores indicating better adjustment/more positive attitudes towards scarring respectively.
Measured: 7-14 days after admission (Timepoint 2 - prior to discharge)
Condition specific statements about treatment and scarring
This includes 4 statements about the patient's treatment and 10 about their scarring, written by the chief investigator and based on clinical experience. The items address how the patient feels about their treatment, their expectations about ongoing treatment and healing and their role in the recovery process. The items focus on the patient's emotional responses to their scars and their perceptions about the impact the scars may have on their quality of life. These items are on a 4-point agreement scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). For the treatment section, the minimum score is 4 and the maximum score is 16, with higher scores indicating better understanding of treatment. and better adjustment/more positive attitudes towards scarring respectively. For the scarring section, the minimum score is 10 and the maximum score is 40, with higher scores indicating better adjustment/more positive attitudes towards scarring respectively.
Measured: 3-months post-injury (Timepoint 3 - follow-up)
Secondary outcomes (2)
Intervention acceptability and feasibility measure
This is a 10-item measure developed specifically for the purpose of this study by the chief investigator. Patients are asked to respond to 6 statements on a 4-point agreement scale (Definitively disagree/Somewhat disagree/Somewhat agree/Definitely agree). This includes items such as 'the videos contained information that was relevant to me' and 'I found the videos upsetting to watch'. The minimum score is 6 and the maximum score is 24, with higher scores indicating higher acceptability and feasibility of the intervention. There are an additional 2 items asking the patient whether the time that they viewed video 1 and video 2 respectively was too soon after the injury, about right or too late after the injury.
Measured: 7-14 days after admission (Timepoint 2 - prior to discharge)
Intervention acceptability and feasibility measure
This is a 10-item measure developed specifically for the purpose of this study by the chief investigator. Patients are asked to respond to 6 statements on a 4-point agreement scale (Definitively disagree/Somewhat disagree/Somewhat agree/Definitely agree). This includes items such as 'the videos contained information that was relevant to me' and 'I found the videos upsetting to watch'. The minimum score is 6 and the maximum score is 24, with higher scores indicating higher acceptability and feasibility of the intervention. There are an additional 2 items asking the patient whether the time that they viewed video 1 and video 2 respectively was too soon after the injury, about right or too late after the injury.
Measured: 3-months post-injury (Timepoint 3 - follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start3 Dec 2020
- Primary completion1 Aug 2021
- Study completion1 Nov 2021
Why it stopped: Unable to recruit during Covid \& funding no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major TraumaStudies 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
- Participants randomised to intervention group (video-viewing) or treatment-as-usual (control) group.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Quarmby, Oxford University Hospitals NHS Trust
- Investigators
- May Quarmby, D Clin, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551157
- Sponsor's protocol ID
- 263694
- Status last verified
- Jan 2023
- First submitted
- 3 Sep 2020
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Adjustment Following Open Fracture: the Impact of Viewing Psychoeducational Video Material.
- ClinicalTrials.gov ID
- NCT04551157
- Acronym / sponsor ID
- 263694
- Conditions
- Major Trauma
- Keywords
- major trauma, open fracture, intervention, appearance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit during Covid \& funding no longer available
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 16 Sep 2020 (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.
The multi-disciplinary team involved in the care of major trauma patients with open fractures has developed two novel patient information videos. They include practical advice from staff about the recovery process, images of the wound throughout the healing process and ways to cope with the range of emotional responses that patients report following an open fracture. The experiences of previous patients are also included. The aim of this project is to evaluate the impact of viewing these videos on patients' ability to follow treatment recommendations made by the team, as well as their psychological and social functioning, as measured by standardised questionnaire responses. Additionally, the patient's experience of viewing the videos, in terms of how relevant and useful they found them, will be evaluated.
Detailed description
High levels of psychological difficulty are often reported by patients with an open fracture. These patients frequently describe feeling distressed by the initial appearance of their scars and can struggle to adjust and prepare for the challenges they face on discharge from hospital. Patients' expectations about the appearance of their wounds and their role in the recovery process may be aided with access to visual material that the patient and their family can revisit as often as is helpful to them.
Therefore, the multi-disciplinary team involved in the care of these patients has developed two novel patient information videos. They include practical advice from staff about the recovery process, images of the wound throughout the healing process and ways to cope with the range of emotional responses that patients report following an open fracture. The experiences of previous patients are also included. The aim of this project is to evaluate the impact of viewing these videos on patients' ability to follow treatment recommendations made by the team, as well as their psychological and social functioning, as measured by standardised questionnaire responses. Additionally, the patient's experience of viewing the videos, in terms of how relevant and useful they found them, will be evaluated.
All adult patients with an open fracture attending the John Radcliffe Hospital Major Trauma Centre will be eligible to take part (unless they have a diagnosis of dementia, active delirium or traumatic brain injury). Participation will involve completing questionnaires whilst in hospital (within the first week and prior to discharge) and at a routine 3-month follow-up appointment. Patients will be randomly selected to either view the videos or receive treatment as usual. The questionnaire responses of patients in these two groups will be compared to help evaluate the videos.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants randomised to intervention group (video-viewing) or treatment-as-usual (control) group.
| Arm | Type | Receives |
|---|---|---|
| Video Viewing | Experimental | Other: Video ViewingParticipants will receive the intervention where they will view two patient information videos. The first video will be viewed within the first week of their inpatient stay and the second video will be viewed just before discharge. |
| Treatment as usual | No intervention | –No change to routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Fluent in English.
- Diagnosed with an open fracture.
- Inpatient stay of >72 hours.
Key exclusion criteria (5 listed)
- Participant has a diagnosis of dementia.
- Participant is experiencing delirium.
- Participant has a complete spinal fracture.
- Participant has a traumatic brain injury with a clinically significant presentation.
- Participant is unable to provide written consent.
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 ViewingTwo patient information videos containing practical advice from staff about the recovery process, images of the wound throughout the healing process and ways to cope with the range of emotional responses that patients report following an open fracture. | Other | Video Viewing |
Primary outcome
Clinical Outcomes Routine Evaluation 10 (CORE-10)
Time frame: 3-7 days after hospital admission (Timepoint 1 - baseline)
The CORE-10 is a brief, generic and easy-to-use measure of psychological distress. It is a self-report questionnaire with ten items about how the respondent has been feeling over the last week, with a 5-point Likert scale (Not at all/Only occasionally/Sometimes/Often/Most of the time). These items cover symptoms (depression, anxiety, trauma, physical problems), functioning (general, social and close relationships sub-domains) and risk to self. All items are summed (items 2 and 3 are reversed scored). The minimum score is 0 and the maximum score is 40, with higher scores indicating higher levels of psychological distress. The clinical cut-off score for general psychological distress is 11.0. The clinical cut-off for depression is 13.0 (sensitivity and specificity values of .92 and 0.72 respectively).
Clinical Outcomes Routine Evaluation 10 (CORE-10)
Time frame: 7-14 days after admission (Timepoint 2 - prior to discharge)
The CORE-10 is a brief, generic and easy-to-use measure of psychological distress. It is a self-report questionnaire with ten items about how the respondent has been feeling over the last week, with a 5-point Likert scale (Not at all/Only occasionally/Sometimes/Often/Most of the time). These items cover symptoms (depression, anxiety, trauma, physical problems), functioning (general, social and close relationships sub-domains) and risk to self. All items are summed (items 2 and 3 are reversed scored). The minimum score is 0 and the maximum score is 40, with higher scores indicating higher levels of psychological distress. The clinical cut-off score for general psychological distress is 11.0. The clinical cut-off for depression is 13.0 (sensitivity and specificity values of .92 and 0.72 respectively).
Clinical Outcomes Routine Evaluation 10 (CORE-10)
Time frame: 3-months post-injury (Timepoint 3 - follow-up)
The CORE-10 is a brief, generic and easy-to-use measure of psychological distress. It is a self-report questionnaire with ten items about how the respondent has been feeling over the last week, with a 5-point Likert scale (Not at all/Only occasionally/Sometimes/Often/Most of the time). These items cover symptoms (depression, anxiety, trauma, physical problems), functioning (general, social and close relationships sub-domains) and risk to self. All items are summed (items 2 and 3 are reversed scored). The minimum score is 0 and the maximum score is 40, with higher scores indicating higher levels of psychological distress. The clinical cut-off score for general psychological distress is 11.0. The clinical cut-off for depression is 13.0 (sensitivity and specificity values of .92 and 0.72 respectively).
Appearance-Related Psychosocial Distress Scale
Time frame: 3-7 days after hospital admission (Timepoint 1 - baseline)
This is an 8-item self-report scale where respondents are asked to disagree or agree to 8 statements about their appearance using a 4-point likert scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). The minimum score is 8 and the maximum is 32, which higher scores indicating higher levels of appearance-related psychosocial distress. Klassen and colleagues (2016) used Rasch Measurement Theory (RMT) analysis to assess the psychometric properties of the measure. Person Separation Index (analogous to a reliability index) and Cronbach alpha values were 0.81 and 0.89 respectively. Convergent and predictive validity of this scale have not yet been assessed.
Appearance-Related Psychosocial Distress Scale
Time frame: 7-14 days after admission (Timepoint 2 - prior to discharge)
This is an 8-item self-report scale where respondents are asked to disagree or agree to 8 statements about their appearance using a 4-point likert scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). The minimum score is 8 and the maximum is 32, which higher scores indicating higher levels of appearance-related psychosocial distress. Klassen and colleagues (2016) used Rasch Measurement Theory (RMT) analysis to assess the psychometric properties of the measure. Person Separation Index (analogous to a reliability index) and Cronbach alpha values were 0.81 and 0.89 respectively. Convergent and predictive validity of this scale have not yet been assessed.
Appearance-Related Psychosocial Distress Scale
Time frame: 3-months post-injury (Timepoint 3 - follow-up)
This is an 8-item self-report scale where respondents are asked to disagree or agree to 8 statements about their appearance using a 4-point likert scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). The minimum score is 8 and the maximum is 32, which higher scores indicating higher levels of appearance-related psychosocial distress. Klassen and colleagues (2016) used Rasch Measurement Theory (RMT) analysis to assess the psychometric properties of the measure. Person Separation Index (analogous to a reliability index) and Cronbach alpha values were 0.81 and 0.89 respectively. Convergent and predictive validity of this scale have not yet been assessed.
Trauma Screening Questionnaire (TSQ)
Time frame: 3-7 days after hospital admission (Timepoint 1 - baseline)
The TSQ is a 10-item self-report questionnaire with items covering the different reactions that sometimes occur after a traumatic event. Respondents are asked to endorse Yes/No to whether or not they have experienced any of the following at least twice in the last week. Predictive validity of respondents who endorsed at least six of the re-experiencing or arousal items (in any combination) was excellent. Sensitivity was 0.86 and specificity was 0.93. Other research by Brewin, Fuchkan, Huntley \& Scragg (2010) has indicated low specificity in non-white samples. Specificity was also low if the TSQ was administered early after the trauma but this improved in the eighteen months following the event.
Trauma Screening Questionnaire (TSQ)
Time frame: 7-14 days after admission (Timepoint 2 - prior to discharge)
The TSQ is a 10-item self-report questionnaire with items covering the different reactions that sometimes occur after a traumatic event. Respondents are asked to endorse Yes/No to whether or not they have experienced any of the following at least twice in the last week. Predictive validity of respondents who endorsed at least six of the re-experiencing or arousal items (in any combination) was excellent. Sensitivity was 0.86 and specificity was 0.93. Other research by Brewin, Fuchkan, Huntley \& Scragg (2010) has indicated low specificity in non-white samples. Specificity was also low if the TSQ was administered early after the trauma but this improved in the eighteen months following the event.
Trauma Screening Questionnaire (TSQ)
Time frame: 3-months post-injury (Timepoint 3 - follow-up)
The TSQ is a 10-item self-report questionnaire with items covering the different reactions that sometimes occur after a traumatic event. Respondents are asked to endorse Yes/No to whether or not they have experienced any of the following at least twice in the last week. Predictive validity of respondents who endorsed at least six of the re-experiencing or arousal items (in any combination) was excellent. Sensitivity was 0.86 and specificity was 0.93. Other research by Brewin, Fuchkan, Huntley \& Scragg (2010) has indicated low specificity in non-white samples. Specificity was also low if the TSQ was administered early after the trauma but this improved in the eighteen months following the event.
General Adherence Measure
Time frame: 3-7 days after hospital admission (Timepoint 1 - baseline)
This is a general measure of patient's adherence to treatment, where respondents are asked how often they were able to adhere to their treatment. It has 5-items and a 6-point Likert response scale (None of the time/A little of the time/Some of the time/A good bit of the time/Most of the time/All of the time). The minimum score is 5 and the maximum score is 24, with higher scores indicating better adherence to treatment. The internal consistency of the measure has been found to be acceptable with a Cronbach's alpha of 0.81 (Hays, n.d).
General Adherence Measure
Time frame: 7-14 days after admission (Timepoint 2 - prior to discharge)
This is a general measure of patient's adherence to treatment, where respondents are asked how often they were able to adhere to their treatment. It has 5-items and a 6-point Likert response scale (None of the time/A little of the time/Some of the time/A good bit of the time/Most of the time/All of the time). The minimum score is 5 and the maximum score is 24, with higher scores indicating better adherence to treatment. The internal consistency of the measure has been found to be acceptable with a Cronbach's alpha of 0.81 (Hays, n.d).
General Adherence Measure
Time frame: 3-months post-injury (Timepoint 3 - follow-up)
This is a general measure of patient's adherence to treatment, where respondents are asked how often they were able to adhere to their treatment. It has 5-items and a 6-point Likert response scale (None of the time/A little of the time/Some of the time/A good bit of the time/Most of the time/All of the time). The minimum score is 5 and the maximum score is 24, with higher scores indicating better adherence to treatment. The internal consistency of the measure has been found to be acceptable with a Cronbach's alpha of 0.81 (Hays, n.d).
Condition specific statements about treatment and scarring
Time frame: 3-7 days after hospital admission (Timepoint 1 - baseline)
This includes 4 statements about the patient's treatment and 10 about their scarring, written by the chief investigator and based on clinical experience. The items address how the patient feels about their treatment, their expectations about ongoing treatment and healing and their role in the recovery process. The items focus on the patient's emotional responses to their scars and their perceptions about the impact the scars may have on their quality of life. These items are on a 4-point agreement scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). For the treatment section, the minimum score is 4 and the maximum score is 16, with higher scores indicating better understanding of treatment. and better adjustment/more positive attitudes towards scarring respectively. For the scarring section, the minimum score is 10 and the maximum score is 40, with higher scores indicating better adjustment/more positive attitudes towards scarring respectively.
Condition specific statements about treatment and scarring
Time frame: 7-14 days after admission (Timepoint 2 - prior to discharge)
This includes 4 statements about the patient's treatment and 10 about their scarring, written by the chief investigator and based on clinical experience. The items address how the patient feels about their treatment, their expectations about ongoing treatment and healing and their role in the recovery process. The items focus on the patient's emotional responses to their scars and their perceptions about the impact the scars may have on their quality of life. These items are on a 4-point agreement scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). For the treatment section, the minimum score is 4 and the maximum score is 16, with higher scores indicating better understanding of treatment. and better adjustment/more positive attitudes towards scarring respectively. For the scarring section, the minimum score is 10 and the maximum score is 40, with higher scores indicating better adjustment/more positive attitudes towards scarring respectively.
Condition specific statements about treatment and scarring
Time frame: 3-months post-injury (Timepoint 3 - follow-up)
This includes 4 statements about the patient's treatment and 10 about their scarring, written by the chief investigator and based on clinical experience. The items address how the patient feels about their treatment, their expectations about ongoing treatment and healing and their role in the recovery process. The items focus on the patient's emotional responses to their scars and their perceptions about the impact the scars may have on their quality of life. These items are on a 4-point agreement scale (Definitely disagree/Somewhat disagree/Somewhat agree/Definitely agree). For the treatment section, the minimum score is 4 and the maximum score is 16, with higher scores indicating better understanding of treatment. and better adjustment/more positive attitudes towards scarring respectively. For the scarring section, the minimum score is 10 and the maximum score is 40, with higher scores indicating better adjustment/more positive attitudes towards scarring respectively.
2 secondary outcomes
Intervention acceptability and feasibility measure
Time frame: 7-14 days after admission (Timepoint 2 - prior to discharge)
Intervention acceptability and feasibility measure
Time frame: 3-months post-injury (Timepoint 3 - follow-up)
Results and safety
The study was stopped early (reason given: Unable to recruit during Covid \& funding no longer available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- 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.
May Quarmby, D Clin principal investigator
Oxford University Hospitals NHS Trust
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 Viewing in people with Major Trauma, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
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 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: stopped early, as of the sponsor's last update on 13 Jan 2023. 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 United Kingdom. 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 was stopped early (reason given: Unable to recruit during Covid \& funding no longer available). Results are not available in the source record.
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?
Clinical Outcomes Routine Evaluation 10 (CORE-10) (time frame: 3-7 days after hospital admission (Timepoint 1 - baseline)). The study lists 15 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 13 Jan 2023.