Chronic Liver DiseaseNCT05241158
Impact of Counselling and Visual Aid on Anxiety in Endoscopic Patients
A study testing Counselling with visual aid and Counselling in people with Chronic Liver Disease and Inflammatory Bowel Diseases, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
A single blind randomized controlled trial was conducted to compare the effect of counselling and visual aid on the anxiety levels in patients undergoing endoscopy and to investigate the superiority of visual aid over psychological counselling and preparation for the procedure in an informed patient. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Liver Disease, Inflammatory Bowel Diseases
- What is being tested?
- Counselling with visual aid and Counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Aug 2018to 4 Feb 2020
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- both genders (male or female) with a minimum age of 18 years
- Able to comprehend questions being asked in Urdu language
- Mentally competent at signing the consent form
Who cannot join
- Patients who were diagnosed cases of psychiatric illnesses
- Undergoing emergency endoscopy (whether diagnostic or therapeutic)
- End stage renal disease
- Hearing difficulty
- Senile dementia
- Pregnant or diagnosed cases of malignancy
- Signs of hepatic encephalopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: State Anxiety Level in Patients Undergoing Upper Gastrointestinal Endoscopy
A single blind randomized controlled trial was conducted to compare the effect of counselling and visual aid on the anxiety levels in patients undergoing endoscopy and to investigate the superiority of visual aid over psychological counselling and preparation for the procedure in an informed patient.
Read the detailed description
A single blind RCT was conducted to assess level of state anxiety between two interventional groups; counselling group and video group. 232 consecutive patients were enrolled from the outpatient department who were scheduled to undergo either a gastroscopy or a colonoscopy (diagnostic or therapeutic). The patients were randomly allocated to one of the two intervention groups (A and B) at the time of endoscopy scheduling. All of the patients received regular instructions regarding gut-preparation at the time of appointment and were also provided with written clear instructions. A gastroenterologist provided information about endoscopy, including the exact preparation instructions and information on the importance of bowel preparation and the adverse effects of the agents used.
Depression Anxiety Stress Scale-42 was administered at baseline. Intervention group A (counselling group) was counselled about the procedure, complications and the post-procedure recovery phase and Group B (video group) was also counselled and shown a 5 minutes animated video of the respective procedure in separate room by gastroenterologist. Endoscopies were carried out by trained doctors (endoscopists) with a minimum experience of 1000 endoscopic procedures. Patients in both the groups were interviewed again after the intervention using Depression Anxiety Stress Scale-42.
- Conditions
- Chronic Liver Disease, Inflammatory Bowel Diseases
- Being tested
- Counselling with visual aid, Counselling
- Keywords
- Endoscopy, Visual Aid, Anxiety, Counselling
- Medical subject headings
- Inflammatory Bowel Diseases, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counselling with visual aidBehavioural
patients were counselled about the procedure, complications and the post-procedure recovery phase and shown a 5 minutes animated video of the gastroscopy or colonoscopy procedure
CounsellingBehavioural
Patients counselled about the procedure, complications and the post-procedure recovery phase
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A: Counselling group Patients were given a briefing about the procedure; the use of local anesthetic along with potential benefits and side effects of the drug. The steps of the endoscopy procedure (gastroscopy or colonoscopy) were explained in detail including the position, intubation, biopsy or intervention wherever applicable, extubation and post-procedure observation period in the recovery room. Detailed instructions were provided regarding post-procedural care, introduction of diet \& follow-up. Receives: Behavioral: Counselling |
| Group B | Active comparator | Group B: Video group Patients in the visual aid group (video group) were provided with the same information mentioned in intervention group A. In addition to that, patients watched a 5 minutes video of the respective procedure. Video showed the animation of a gastroscopy or colonoscopy procedure with a voice over explaining all the steps of the procedure in addition to the pre and post-procedure precautions to be observed. Receives: Behavioral: Counselling with visual aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Depression Anxiety Stress Scale-42 (DASS-42) was used to measure state anxiety of the patients undergoing endoscopy before and after intervention.. Score on anxiety scale ranges from 0 to 20+. 0-7 is normal, 8-9 is mild, 10-14 is moderate, 15-19 is severe and 20+ is extremely severe anxiety. The higher score on anxiety scale, the higher the level of anxiety among participants.
Measured: 90 minutes
Secondary outcomes (2)
fear
Visual analogue scale was used to measure fear of the patients undergoing endoscopy before and after intervention. Participants were asked to rate the intensity of fear on a scale of 0-10. 0 means no fear and 10 means worst fear possible.
Measured: 90 minutes
Stress
Depression Anxiety Stress Scale-42 (DASS-42) was used to measure stress of the patients undergoing endoscopy before and after intervention. Score on stress scale ranges from 0 to 34+. 0-14 is normal, 15-18 is mild, 19-25 is moderate, 26-33 is severe and 34+ is extremely severe stress. The higher score on stress scale, the higher the level of stress among participants.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start16 Aug 2018
- Primary completion4 Feb 2020
- Study completion4 Feb 2020
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 Chronic Liver DiseaseStudies 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
- The patients were then randomly allocated between two groups (group 1 watched animated video of endoscopy procedure, however, group 2 didn't watch any video) on a 1:1 ratio using permuted block randomization with a fixed block sizes of four, by a house officer who wasn't involved in providing intervention to any group or in assisting any of the endoscopy procedures. The allocation sequence to the study conditions was kept concealed from psychologists measuring outcome variables, using sequentially numbered, opaque and sealed envelopes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ali asad, King Edward Medical University
- Investigators
- Ali Asad Khan, FCPS, Principal investigator, King Edward Medical UniversityAnam Ali, MS, Principal investigator, University of Child Health Sciences & The Children's Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241158
- Sponsor's protocol ID
- 179/RC/KEMU
- Status last verified
- Nov 2022
- First submitted
- 5 Feb 2022
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khan AA, Ali A, Khan AS, Shafi Y, Masud M, Irfan F, Abaidullah S. Effects of visual aid on state anxiety, fear and stress level in patients undergoing endoscopy: a randomized controlled trial. Ann Med. 2023 Dec;55(1):1234-1243. doi: 10.1080/07853890.2023.2191000.
PubMed 37078544
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- State Anxiety Level in Patients Undergoing Upper Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT05241158
- Acronym / sponsor ID
- 179/RC/KEMU
- Conditions
- Chronic Liver Disease, Inflammatory Bowel Diseases
- Keywords
- Endoscopy, Visual Aid, Anxiety, Counselling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 4 Feb 2020 (actual)
- Study completion
- 4 Feb 2020 (actual)
- First posted
- 15 Feb 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.
A single blind randomized controlled trial was conducted to compare the effect of counselling and visual aid on the anxiety levels in patients undergoing endoscopy and to investigate the superiority of visual aid over psychological counselling and preparation for the procedure in an informed patient.
Detailed description
A single blind RCT was conducted to assess level of state anxiety between two interventional groups; counselling group and video group. 232 consecutive patients were enrolled from the outpatient department who were scheduled to undergo either a gastroscopy or a colonoscopy (diagnostic or therapeutic). The patients were randomly allocated to one of the two intervention groups (A and B) at the time of endoscopy scheduling. All of the patients received regular instructions regarding gut-preparation at the time of appointment and were also provided with written clear instructions. A gastroenterologist provided information about endoscopy, including the exact preparation instructions and information on the importance of bowel preparation and the adverse effects of the agents used.
Depression Anxiety Stress Scale-42 was administered at baseline. Intervention group A (counselling group) was counselled about the procedure, complications and the post-procedure recovery phase and Group B (video group) was also counselled and shown a 5 minutes animated video of the respective procedure in separate room by gastroenterologist. Endoscopies were carried out by trained doctors (endoscopists) with a minimum experience of 1000 endoscopic procedures. Patients in both the groups were interviewed again after the intervention using Depression Anxiety Stress Scale-42.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The patients were then randomly allocated between two groups (group 1 watched animated video of endoscopy procedure, however, group 2 didn't watch any video) on a 1:1 ratio using permuted block randomization with a fixed block sizes of four, by a house officer who wasn't involved in providing intervention to any group or in assisting any of the endoscopy procedures. The allocation sequence to the study conditions was kept concealed from psychologists measuring outcome variables, using sequentially numbered, opaque and sealed envelopes.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Behavioral: CounsellingGroup A: Counselling group Patients were given a briefing about the procedure; the use of local anesthetic along with potential benefits and side effects of the drug. The steps of the endoscopy procedure (gastroscopy or colonoscopy) were explained in detail including the position, intubation, biopsy or intervention wherever applicable, extubation and post-procedure observation period in the recovery room. Detailed instructions were provided regarding post-procedural care, introduction of diet \& follow-up. |
| Group B | Active comparator | Behavioral: Counselling with visual aidGroup B: Video group Patients in the visual aid group (video group) were provided with the same information mentioned in intervention group A. In addition to that, patients watched a 5 minutes video of the respective procedure. Video showed the animation of a gastroscopy or colonoscopy procedure with a voice over explaining all the steps of the procedure in addition to the pre and post-procedure precautions to be observed. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- both genders (male or female) with a minimum age of 18 years
- Able to comprehend questions being asked in Urdu language
- Mentally competent at signing the consent form
Key exclusion criteria (7 listed)
- Patients who were diagnosed cases of psychiatric illnesses
- Undergoing emergency endoscopy (whether diagnostic or therapeutic)
- End stage renal disease
- Hearing difficulty
- Senile dementia
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 |
|---|---|---|
| Counselling with visual aidpatients were counselled about the procedure, complications and the post-procedure recovery phase and shown a 5 minutes animated video of the gastroscopy or colonoscopy procedure | Behavioural | Group B |
| CounsellingPatients counselled about the procedure, complications and the post-procedure recovery phase | Behavioural | Group A |
Primary outcome
Anxiety
Time frame: 90 minutes
Depression Anxiety Stress Scale-42 (DASS-42) was used to measure state anxiety of the patients undergoing endoscopy before and after intervention.. Score on anxiety scale ranges from 0 to 20+. 0-7 is normal, 8-9 is mild, 10-14 is moderate, 15-19 is severe and 20+ is extremely severe anxiety. The higher score on anxiety scale, the higher the level of anxiety among participants.
2 secondary outcomes
fear
Time frame: 90 minutes
Stress
Time frame: 90 minutes
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 18 Nov 2022.
- Derived from this study: PubMed 37078544Khan AA, Ali A, Khan AS, Shafi Y, Masud M, Irfan F, Abaidullah S. Effects of visual aid on state anxiety, fear and stress level in patients undergoing endoscopy: a randomized controlled trial. Ann Med. 2023 Dec;55(1):1234-1243. doi: 10.1080/07853890.2023.2191000.
- 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.
Ali Asad Khan, FCPS principal investigator
King Edward Medical University
Anam Ali, MS principal investigator
University of Child Health Sciences & The Children's Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counselling with visual aid and Counselling in people with Chronic Liver Disease and Inflammatory Bowel Diseases, run by King Edward Medical University at 1 site in Pakistan.
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 3 inclusion and 7 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 18 Nov 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 Pakistan. 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?
Anxiety (time frame: 90 minutes). 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 NCT05241158, 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 18 Nov 2022.