Pain, PostoperativeNCT06265376
Do Patient Educational Videos Improve Pain and Recovery After Laparoscopic Hysterectomy?
A study testing Educational Video in people with Pain, Postoperative, run by Benaroya Research Institute at 1 site in United States.
Trial summary
The use of multi-model patient education has been used in a variety of medical specialties to educate patients on expectations for various medical procedures and improve patients' understanding of their own health care. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Educational Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2023to 28 Apr 2024
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18y/o or older
- planned for a laparoscopic hysterectomy for benign indications
Who cannot join
- inability to consent
- language other than English
- conversion to laparotomy, vNOTES (a type of laparoscopic assisted vaginal hysteroectomy)
- vaginal hysterectomy
- chronic opioid use prior to surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Mason Medical Center
Seattle, Washington, 98101
About this study
Official title: A Single-site Randomized Controlled Trial of an Patient Educational Video to Improve Postoperative Pain and Overall Recovery Satisfaction After Laparoscopic Hysterectomy Benign Indication
The use of multi-model patient education has been used in a variety of medical specialties to educate patients on expectations for various medical procedures and improve patients' understanding of their own health care. However, it is unknown what type of audio and/or visual materials work best in a given clinical setting. By surveying overall pain/post-operative recovery satisfaction we can measure how well our video intervention educates and reinforces post-operative management at home when compared to the current method of education that patients receive at the pre-operative visit prior to laparoscopic hysterectomy at this institution.
- Conditions
- Pain, Postoperative
- Being tested
- Educational Video
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational VideoBehavioural
A recorded educational video will be presented to the patient prior to meeting with the provider at the presurgical meeting
| Study group | Role | What they receive |
|---|---|---|
| Educational Video Intervention | Experimental | Participants have been randomly selected into this arm to receive intervention via the educational video in addition to regular treatment and recovery options. Receives: Behavioral: Educational Video |
| No Intervention | No intervention | Participants have been randomly selected into this arm to not receive intervention and continue with regular treatment and recovery options. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall satisfaction score (5 point Likert scale) with post operative pain control after laparoscopic hysterectomy
To determine if video education on post-operative pain management and expectations can improve patients' overall satisfaction with post operative pain control after laparoscopic hysterectomy
Measured: Within 10 days post surgery
Secondary outcomes (9)
Pain score at the time of survey completion (0=no pain 10=worst pain
To determine if video education on post-operative pain management and expectations improves patient post operative pain scores at the time of post-op phone call
Measured: Within 10 days post surgery
Average pain score for the first 7 days as perceived by the patients (likert scale)
To determine if video education on post-operative pain management and expectations improves patient perceived post operative pain control throughout the first 7 day post-op
Measured: Within 10 days post surgery
Number of post-op phone calls received
To determine if video education on post-operative pain management and expectations decreases the number of post- operative phone calls received by providers during the first week post-op
Measured: Within 10 days post surgery
Number of post-op emergency room visits
To determine if video education on post-operative pain management and expectations decreases the number of post- operative emergency room visits by patients during the first week post-op
Measured: Within 10 days post surgery
Number of readmissions
To determine if video education on post-operative pain management and expectations decreases the number of postoperative readmissions by patients during the first week post-op
Measured: Within 10 days post surgery
Number of patients with steri-strips still in place
To determine if video education on post-operative pain management and expectations decreases the number of patients who have not removed their steri-strips by day 7
Measured: Within 10 days post surgery
Number opioids taken since surgery
To determine if video education on post-operative pain management and expectations decreased the number of narcotics used post-operatively
Measured: Within 10 days post surgery
Overall satisfaction with pre-operative education regarding surgery (5 point Likert scale)
To determine if video education on post-operative pain management and expectations improves overall satisfaction with pre-operative education regarding surgery
Measured: Within 10 days post surgery
ding surgery (5 point likert scale) Overall satisfaction with educations regarding what to expect post-operatively (5 point Likert scale)
To determine if video education on post-operative pain management and expectations improves overall satisfaction with educations regarding what to expect post-operatively
Measured: Within 10 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start13 Mar 2023
- Primary completion28 Apr 2024
- Study completion28 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benaroya Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Loring, Benaroya Research Institute
- Investigators
- Megan Loring, MD, Principal investigator, Virginia Mason Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265376
- Sponsor's protocol ID
- IRB22-046
- Status last verified
- Aug 2024
- First submitted
- 4 Jan 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-site Randomized Controlled Trial of an Patient Educational Video to Improve Postoperative Pain and Overall Recovery Satisfaction After Laparoscopic Hysterectomy Benign Indication
- ClinicalTrials.gov ID
- NCT06265376
- Acronym / sponsor ID
- IRB22-046
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Benaroya Research InstituteUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 28 Apr 2024 (actual)
- Study completion
- 28 Apr 2024 (actual)
- First posted
- 20 Feb 2024 (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 use of multi-model patient education has been used in a variety of medical specialties to educate patients on expectations for various medical procedures and improve patients' understanding of their own health care. However, it is unknown what type of audio and/or visual materials work best in a given clinical setting. By surveying overall pain/post-operative recovery satisfaction we can measure how well our video intervention educates and reinforces post-operative management at home when compared to the current method of education that patients receive at the pre-operative visit prior to laparoscopic hysterectomy at this institution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Video Intervention | Experimental | Behavioral: Educational VideoParticipants have been randomly selected into this arm to receive intervention via the educational video in addition to regular treatment and recovery options. |
| No Intervention | No intervention | –Participants have been randomly selected into this arm to not receive intervention and continue with regular treatment and recovery options. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18y/o or older
- planned for a laparoscopic hysterectomy for benign indications
Key exclusion criteria (5 listed)
- inability to consent
- language other than English
- conversion to laparotomy, vNOTES (a type of laparoscopic assisted vaginal hysteroectomy)
- vaginal hysterectomy
- chronic opioid use prior to surgery
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 VideoA recorded educational video will be presented to the patient prior to meeting with the provider at the presurgical meeting | Behavioural | Educational Video Intervention |
Primary outcome
Overall satisfaction score (5 point Likert scale) with post operative pain control after laparoscopic hysterectomy
Time frame: Within 10 days post surgery
To determine if video education on post-operative pain management and expectations can improve patients' overall satisfaction with post operative pain control after laparoscopic hysterectomy
9 secondary outcomes
Pain score at the time of survey completion (0=no pain 10=worst pain
Time frame: Within 10 days post surgery
Average pain score for the first 7 days as perceived by the patients (likert scale)
Time frame: Within 10 days post surgery
Number of post-op phone calls received
Time frame: Within 10 days post surgery
Number of post-op emergency room visits
Time frame: Within 10 days post surgery
Number of readmissions
Time frame: Within 10 days post surgery
Number of patients with steri-strips still in place
Time frame: Within 10 days post surgery
Number opioids taken since surgery
Time frame: Within 10 days post surgery
Overall satisfaction with pre-operative education regarding surgery (5 point Likert scale)
Time frame: Within 10 days post surgery
ding surgery (5 point likert scale) Overall satisfaction with educations regarding what to expect post-operatively (5 point Likert scale)
Time frame: Within 10 days post surgery
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 23 Aug 2024.
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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.
Megan Loring, MD principal investigator
Virginia Mason Medical Center
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 Video in people with Pain, Postoperative, run by Benaroya Research Institute at 1 site in United States.
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 2 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 23 Aug 2024. 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 States. 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?
Overall satisfaction score (5 point Likert scale) with post operative pain control after laparoscopic hysterectomy (time frame: Within 10 days post 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 23 Aug 2024.