- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04610151
The Effects of Guided Imagery on Postoperative Pain Management
October 29, 2020 updated by: Leyla ZENGİN AYDIN, Dicle University
The Effects of Guided Imagery on Postoperative Pain Management: A Randomized Controlled Trial
This study was conducted to determine the effects of guided imagery on postoperative pain management.
Study Overview
Detailed Description
The sample of the study consisted of 60 patients (30 in the experiment and 30 in the control groups) undergoing lower extremity operations at the orthopedics clinics of the Kahramanmaras Necip Fazil City Hospital.
The study was conducted between April and September 2018.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sur
-
Diyarbakır, Sur, Turkey, 21280
- Leyla ZENGİN AYDIN
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients at and over the age of 18
- Patients who were able to speak Turkish
- Patients who received spinal anesthesia
Exclusion Criteria:
- Patients who had not previously used guided imagery
- Patients any disease that could cause pain outside the surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Guided Imagery
Guided Imagery Intervention:The pretest data of the patients with a pain score of 4 or higher according to VAS were collected.
Afterwards, the experiment group patients were applied guided imagery.
|
Guided Imagery CD: A guided imagery CD was prepared by a web designer with the recommendations of the researcher to include relaxing, soft and slow-paced, mixed nature sounds and photographs towards reducing pain in lower extremity surgical operation patients.
The directives used for guidance, the audio recordings created as a result of literature review and the video lasted for 13 minutes (
|
NO_INTERVENTION: No-Reflexology Application , control group.
No intervention was applied on the control group patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A mean total score on the Visual Analogue Scale (VAS)
Time Frame: first week
|
A mean total score on the VAS of four and above indicates postoperative pain.
|
first week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2018
Primary Completion (ACTUAL)
June 30, 2018
Study Completion (ACTUAL)
September 30, 2018
Study Registration Dates
First Submitted
October 26, 2020
First Submitted That Met QC Criteria
October 29, 2020
First Posted (ACTUAL)
October 30, 2020
Study Record Updates
Last Update Posted (ACTUAL)
October 30, 2020
Last Update Submitted That Met QC Criteria
October 29, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LZA2018/5
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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