- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06229028
Examining the Effects of Patient Information Forms, Exercise Forms and Video Recordings
Examining the Effects of Patient Information Forms, Exercise Forms and Video Recordings on Clinical and Functional Results in Patients With Hand and Forearm Injuries.
Study Overview
Status
Conditions
Detailed Description
Written and visual information can affect outcome measurements in health care. In addition to verbal information and guidance, written and visual information is also frequently recommended. This information increases patients' clinical knowledge, communication, and satisfaction and reduces potential anxiety.
Forms have been created in various medical fields to inform the patient about medications, applications, and possible risks, and there are many studies on these instruction forms. The effectiveness of patient information forms and exercise forms in physiotherapy and occupational therapy has gained importance in recent years. It is used in areas such as athlete rehabilitation, impingement syndrome, and osteoarthritis.
However, only one study was found, especially in the field of hand rehabilitation.
The aim of planning this study is to examine the contribution of patient information forms, exercise forms, and video recordings to the clinical and functional results of patients who suffered hand and forearm injuries as a result of a work accident.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hande Usta, PhD
- Phone Number: +905068209000
- Email: husta@pau.edu.tr
Study Contact Backup
- Name: Umut Eraslan, PhD
- Phone Number: +905444126520
- Email: ueraslan@pau.edu.tr
Study Locations
-
-
Deni̇zli̇
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Merkez, Deni̇zli̇, Turkey
- Recruiting
- Pamukkale University
-
Contact:
- Hande Usta, PhD
- Phone Number: +905068209000
- Email: husta@pau.edu.tr
-
Contact:
- Umut Eraslan, PhD
- Phone Number: +905444126520
- Email: ueraslan@pau.edu.tr
-
Principal Investigator:
- Ahmet Fahir Demirkan, Professor
-
Principal Investigator:
- Ali Kitis, Professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- who have a hand or forearm injury as a result of a work-related injury
- who has undergone primary surgery/conservative treatment related to the injury
- who is literate
- who has and can use technological equipment to use visual and audio communication materials (video)
Exclusion Criteria:
- who miss the evaluations
- who wants to leave the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: verbal explanation group
The treatment by the diagnosis will be explained under the guidance of the therapist and will be repeated at each appointment to the first group.
|
Patients in all groups will undergo a 12-week hand rehabilitation process that includes the use of appropriate orthoses if necessary, approaches to edema and pain, restoration of joint range of motion, strengthening, and functional return to work or activities.
The application of the rehabilitation process will change according to the assigned group.
|
Experimental: patient information and exercise forms group
Treatment by the diagnosis will be provided with patient information and exercise forms containing visual and written information in addition to an explanation under the guidance of the therapist for the second group.
|
hand rehabilitation with patient information and exercise forms
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Experimental: video recording group
Treatment by diagnosis will be provided with patient information containing visual and written information, exercise forms, and video recording, in addition to narration under the guidance of the therapist for the third group.
|
hand rehabilitation with video recording
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of Event Scale-Revised
Time Frame: The evaluation were completed in the first session when the patient applied to the hand rehabilitation unit, and it was also repeated at 3th months after the surgery or conservative treatment.
|
This scale is a 22-item self-report measure that assesses subjective distress caused by traumatic events.
Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely").
The total score ranges from 0 to 88.
A higher score indicates more affection for the traumatic event.
|
The evaluation were completed in the first session when the patient applied to the hand rehabilitation unit, and it was also repeated at 3th months after the surgery or conservative treatment.
|
State-trait Anxiety Inventory
Time Frame: The evaluation were completed in the first session when the patient applied to the hand rehabilitation unit, and it was also repeated at 3th months after the surgery or conservative treatment.
|
This inventory was developed by Spielberger et al. (1970) to measure anxiety from the perspective of states vs. traits.
The state measurement assesses how the individual feels "right now" or at this moment.
The range of possible scores is from a minimum score of 20 to a maximum score of 80. Scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
|
The evaluation were completed in the first session when the patient applied to the hand rehabilitation unit, and it was also repeated at 3th months after the surgery or conservative treatment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grip and Pinch Strength
Time Frame: The evaluation were completed in the first session when the patient applied to the hand rehabilitation unit, and it was also repeated at 3th months after the surgery or conservative treatment.
|
Grip and Pinch Strength strength is measured in pounds, kilograms by squeezing a dynamometer and a pinchmeter about three times in each hand.
|
The evaluation were completed in the first session when the patient applied to the hand rehabilitation unit, and it was also repeated at 3th months after the surgery or conservative treatment.
|
Michigan Hand Outcomes Questionnaire
Time Frame: The evaluation were completed in the first session when the patient applied to the hand rehabilitation unit, and it was also repeated at 3th months after the surgery or conservative treatment.
|
This Questionnaire is a tool used to assess patients with hand disorders through the measurement of 6 health domains: overall hand function, activities of daily living, pain, work performance, aesthetics, and patient satisfaction.
An overall score can be obtained by summing the scores for all six scales after reversing the pain scale (pain=100-pain score) and then dividing by six.
On the pain scale, high scores indicate greater pain, while on the other five scales, high scores denote better hand performance.
|
The evaluation were completed in the first session when the patient applied to the hand rehabilitation unit, and it was also repeated at 3th months after the surgery or conservative treatment.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: ALI KITIS, Professor, Pamukkale University Faculty of Physiotherapy and Rehabilitation
- Study Director: AHMET FAHİR DEMIRKAN, Professor, Pamukkale University Faculty of Medicine
Publications and helpful links
General Publications
- Abu Abed M, Himmel W, Vormfelde S, Koschack J. Video-assisted patient education to modify behavior: a systematic review. Patient Educ Couns. 2014 Oct;97(1):16-22. doi: 10.1016/j.pec.2014.06.015. Epub 2014 Jul 5.
- Barton CJ, Rathleff MS. 'Managing My Patellofemoral Pain': the creation of an education leaflet for patients. BMJ Open Sport Exerc Med. 2016 Mar 31;2(1):e000086. doi: 10.1136/bmjsem-2015-000086. eCollection 2016.
- Snyder-Ramos SA, Seintsch H, Bottiger BW, Motsch J, Martin E, Bauer M. Patient satisfaction and information gain after the preanesthetic visit: a comparison of face-to-face interview, brochure, and video. Anesth Analg. 2005 Jun;100(6):1753-1758. doi: 10.1213/01.ANE.0000153010.49776.E5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-60116787-020-468698
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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