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The Effect of Preoperative Explanatory Videos in Total Extraperitoneal Inguinal Hernioplasty on Information Providing: a Multicenter Randomized Controlled Trial

Primary Purpose

Inguinal Hernia

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Explanatory video
Informed consent form
Sponsored by
Kantonsspital Winterthur KSW
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Inguinal Hernia focused on measuring inguinal hernia, informed consent, STAI, ICF, State-Trait Anxiety Inventory, Individual Clinician Feedback

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • unilateral or bilateral hernia with indication for surgical therapy
  • signed informed consent form for trial participation

Exclusion Criteria:

  • Patients who have had surgery for ipsi- or contralateral inguinal or femoral hernia
  • combination interventions (umbilical and inguinal hernia repair, e.g.)
  • cognitive, audio-visual or linguistic handicap raising concern of complete understanding of the research project

Sites / Locations

  • GZO Spital WetzikonRecruiting
  • Cantonal Hospital Winterthur, Department of SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Sham Comparator

Arm Label

Hernia video

Mock video

Control group

Arm Description

The video of the intervention group will provide a short (< 5 min) summary explaining the basic principles of endoscopic extraperitoneal hernia repair, its possible complications and the postoperative course. After carefully watching the video, participants should be able to correctly answer to a multiple-choice test consisting of 12 questions related to the aforementioned topics.

This video is a general documentation of the "typical" day of surgery in the day clinic. The information is essentially limited to the pictorial representation of the individual wards which the patient will pass through during the operation (arrival at the clinic, admission, transport to the operating theatre, recovery room, discharge). The video explicitly does not transport any information that could be helpful for answering the quiz questions or for medical understanding of the operation itself.

The link of the third group leads to a digital version of the information sheet, which has already been discussed with all patients during the informed consent discussion. The digital version of the informed consent form allows the patient to read the information again. The third group thus corresponds to the standard of care.

Outcomes

Primary Outcome Measures

Score in multiple-choice-test
Quiz with questions regarding background, indication, implementation, complications and postoperative course of the total extraperitoneal inguinal h ernioplasty (TEP) procedure. The questions asked check relevant aspects for the patient with regard to the planned operation. The structure of the multiple-choice quiz takes the "single best option" out of 12 questions. Maximum value of the test is 12 (12/12, highest score-best outcome), the lowest 0 (0/12, lowest score-worst outcome). The questions are clearly posed and the correct answer is based on current guidelines for the management of inguinal hernia, which have been published by the European Hernia Society (EHS), American Hernia Society (AHS), International Endo Hernia Society (IEHS) and the European Association for Endoscopic Surgery and Other Interventional Techniques (EAES) as a consensus document by "HerniaSurge".

Secondary Outcome Measures

Spielberg State-Trait Anxiety Inventory (STAI)
To test the effect of the intervention on anxiety before surgery, an anxiety score is determined using the Spielberg State-Trait Anxiety Inventory (STAI). The inventory is based on a 4-point Likert scale and consists of 40 questions on a self-report basis. Scores range from 20 to 80 with higher scores indicating greater anxiety.
Individual Clinician Feedback (ICF)
Patient satisfaction with regard to doctor-patient communication is recorded by the validated ICF questionnaire. The ICF questionnaire (Picker Institute) comprises 38 items concerning the patient's experience of the examination atmosphere, the comprehensibility of the physician's statements, the participation in decisions, the course of the conversation as well as socio-demographic characteristics of the patient. The items are assessed on an 11-point Likert scale from 0 to 10, with 0 as the most critical and 10 as the most positive experience.
Numerical rating scale (NRS)
To assess the effect on chronic pain, the pain is assessed by telephone using the NRS score approximately 3 months after the operation. The numerical rating scale (NRS) requires the patient to rate his or her pain on a scale from 0 to 10, in which 0 is no pain (best outcome) and 10 the worst pain imaginable (worst outcome).

Full Information

First Posted
July 13, 2020
Last Updated
October 27, 2022
Sponsor
Kantonsspital Winterthur KSW
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1. Study Identification

Unique Protocol Identification Number
NCT04494087
Brief Title
The Effect of Preoperative Explanatory Videos in Total Extraperitoneal Inguinal Hernioplasty on Information Providing: a Multicenter Randomized Controlled Trial
Official Title
Potential Benefit in Information Providing and Influence on Patient Anxiety and Satisfaction by Means of Preoperative Explanatory Videos in Total Extraperitoneal Inguinal Hernioplasty: a Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kantonsspital Winterthur KSW

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The use of electronic media in informed consent giving has become increasingly important in recent years. Due to the easy access to information via electronical media, patients are primed in a heterogeneous manner concerning expectations and wishes regarding surgical interventions. Inherent to its nature elective interventions are critically questioned as there is time for information gathering and reflection. In this study, the investigators set out to investigate the effect of an educational video as a supporting element in the process of informed consent giving for one the most frequently performed interventions in general surgery, namely inguinal hernia repair. In a multi-center setup, eligible patients for primary inguinal hernia repair will be randomly assigned to 1 of 3 groups. The intervention video provides basic principles of endoscopic extraperitoneal hernia repair. The second video is similar in length and design and displays general aspects of day surgery in the two study centres. The third group's link will lead to the digital version of the informed consent. Primary outcomes will consist of 1) score in a multiple choice test assessing gain of knowledge regarding hernia repair, 2) difference in the State-Trait Anxiety Inventory (STAI) and 3) patient satisfaction questionnaire (ICF, Picker Institute, Germany) as assessed 1-2 days after the first consultation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
inguinal hernia, informed consent, STAI, ICF, State-Trait Anxiety Inventory, Individual Clinician Feedback

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
183 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hernia video
Arm Type
Active Comparator
Arm Description
The video of the intervention group will provide a short (< 5 min) summary explaining the basic principles of endoscopic extraperitoneal hernia repair, its possible complications and the postoperative course. After carefully watching the video, participants should be able to correctly answer to a multiple-choice test consisting of 12 questions related to the aforementioned topics.
Arm Title
Mock video
Arm Type
Placebo Comparator
Arm Description
This video is a general documentation of the "typical" day of surgery in the day clinic. The information is essentially limited to the pictorial representation of the individual wards which the patient will pass through during the operation (arrival at the clinic, admission, transport to the operating theatre, recovery room, discharge). The video explicitly does not transport any information that could be helpful for answering the quiz questions or for medical understanding of the operation itself.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
The link of the third group leads to a digital version of the information sheet, which has already been discussed with all patients during the informed consent discussion. The digital version of the informed consent form allows the patient to read the information again. The third group thus corresponds to the standard of care.
Intervention Type
Other
Intervention Name(s)
Explanatory video
Intervention Description
Links to explanatory videos handed out to patients to be watched at home after standard informed consent giving
Intervention Type
Other
Intervention Name(s)
Informed consent form
Intervention Description
Links to a digital version of the informed consent form already discussed during the process of informed consent giving.
Primary Outcome Measure Information:
Title
Score in multiple-choice-test
Description
Quiz with questions regarding background, indication, implementation, complications and postoperative course of the total extraperitoneal inguinal h ernioplasty (TEP) procedure. The questions asked check relevant aspects for the patient with regard to the planned operation. The structure of the multiple-choice quiz takes the "single best option" out of 12 questions. Maximum value of the test is 12 (12/12, highest score-best outcome), the lowest 0 (0/12, lowest score-worst outcome). The questions are clearly posed and the correct answer is based on current guidelines for the management of inguinal hernia, which have been published by the European Hernia Society (EHS), American Hernia Society (AHS), International Endo Hernia Society (IEHS) and the European Association for Endoscopic Surgery and Other Interventional Techniques (EAES) as a consensus document by "HerniaSurge".
Time Frame
assessed 1-2 days after group allocation/exposure
Secondary Outcome Measure Information:
Title
Spielberg State-Trait Anxiety Inventory (STAI)
Description
To test the effect of the intervention on anxiety before surgery, an anxiety score is determined using the Spielberg State-Trait Anxiety Inventory (STAI). The inventory is based on a 4-point Likert scale and consists of 40 questions on a self-report basis. Scores range from 20 to 80 with higher scores indicating greater anxiety.
Time Frame
assessed 1-2 days after group allocation/exposure
Title
Individual Clinician Feedback (ICF)
Description
Patient satisfaction with regard to doctor-patient communication is recorded by the validated ICF questionnaire. The ICF questionnaire (Picker Institute) comprises 38 items concerning the patient's experience of the examination atmosphere, the comprehensibility of the physician's statements, the participation in decisions, the course of the conversation as well as socio-demographic characteristics of the patient. The items are assessed on an 11-point Likert scale from 0 to 10, with 0 as the most critical and 10 as the most positive experience.
Time Frame
assessed 30 days postoperatively at follow-up visit
Title
Numerical rating scale (NRS)
Description
To assess the effect on chronic pain, the pain is assessed by telephone using the NRS score approximately 3 months after the operation. The numerical rating scale (NRS) requires the patient to rate his or her pain on a scale from 0 to 10, in which 0 is no pain (best outcome) and 10 the worst pain imaginable (worst outcome).
Time Frame
assessed 3 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: unilateral or bilateral hernia with indication for surgical therapy signed informed consent form for trial participation Exclusion Criteria: Patients who have had surgery for ipsi- or contralateral inguinal or femoral hernia combination interventions (umbilical and inguinal hernia repair, e.g.) cognitive, audio-visual or linguistic handicap raising concern of complete understanding of the research project
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabian Lunger, MD,PhD
Phone
+41 052 266 21 21
Email
fabian.lunger@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Gingert, MD
Organizational Affiliation
Cantonal Hospital Winterthur, Department of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
GZO Spital Wetzikon
City
Wetzikon
ZIP/Postal Code
8620
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Cantonal Hospital Winterthur, Department of Surgery
City
Winterthur
ZIP/Postal Code
8400
Country
Switzerland
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data (IPD) with other researchers.
Citations:
PubMed Identifier
33500291
Citation
Lunger F, Frank F, Peros G, Lunger A, Vuille-Dit-Bille R, Guglielmetti L, Breitenstein S, Grieder F, Ehlers J, Gingert C. Potential benefit in information providing and influence on patient anxiety and satisfaction by means of preoperative explanatory videos in total extraperitoneal inguinal hernioplasty: study protocol of a multicentre, double-blinded, randomised parallel-group controlled trial. BMJ Open. 2021 Jan 26;11(1):e043702. doi: 10.1136/bmjopen-2020-043702.
Results Reference
derived

Learn more about this trial

The Effect of Preoperative Explanatory Videos in Total Extraperitoneal Inguinal Hernioplasty on Information Providing: a Multicenter Randomized Controlled Trial

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