- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06688773
THE EFFECT OF RELAXATION EXERCİSE ON COMFORT AND ANXIETY IN HERNIATED LUMBAR DISC SURGERY
November 12, 2024 updated by: Didem Ayhan, Bandırma Onyedi Eylül University
THE EFFECT OF PROGRESSIVE RELAXATION EXERCISES ON COMFORT AND ANXIETY LEVEL OF PATIENTS WITH LUMBAR DISC HERNIATION SURGERY: CLINICAL TRIAL
This study aimed to investigate the effect of progressive relaxation exercises on the comfort and anxiety levels of patients undergoing lumbar disc herniation surgery in the neurosurgery clinic.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study aimed to investigate the effect of progressive relaxation exercises on the comfort and anxiety levels of patients undergoing lumbar disc herniation surgery in the neurosurgery clinic.The study's data was conducted as experimental study on patients who will undergo surgery in the neurosurgery clinic of the Ministry of Health Muammer Ağım Gemlik State Hospital between March 2023 and July 2023.
The sociodemographic Characteristics Questionnaire, Immobilisation Comfort Scale and State Anxiety Scale were used for data collection.
The Shapiro-Wilk normality test, the t-test for the same and different groups mean and standard deviation, Pearson correlation analysis were used to evaluate the data.
Study Type
Interventional
Enrollment (Actual)
42
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
-
-
Gemlik
-
Bursa, Gemlik, Turkey
- Gemlik Muammer Ağım State Hospital
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Over 18 years of age, elective surgery,
- Undergoing LDH surgery for the first time,
- Undergoing lumbarmicrodiscectomy surgery,
- ASA 1 and 2 classification,
- Receiving only general anaesthesia under endotracheal intubation,
- Without cognitive impairment, hearing and vision problems,
- Volunteered to participate in the study,
- Patients who did not develop any complications that would affect comfort and anxiety
Exclusion Criteria:
- 18 years of age or younger,
- With psychiatric disorders,
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: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: progressive relaxation exercises group
|
In this study, the relaxation exercises CD, which is a material created by the Turkish Psychological Association, was used.
This CD consists of three parts.
The first part consists of 10 minutes and this part explains the definition and purpose of deep relaxation exercise and the points to be considered during the exercise.
The second part of the CD consists of 30 minutes of verbal explanation of the items of relaxation exercises accompanied by the sound of a stream.
The third part consists of 30 minutes and includes only relaxation music.
Other Names:
|
|
Other: Control group
Implementation of standart postoperative care in the clinical setting.
|
Routine postoperative patient care in the clinic was applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comfort
Time Frame: Comfort levels of the patients were measured on the morning of the first postoperative day (before mobilisation)
|
Measured using the "Immobilisation Comfort Scale".
The total scores obtained from the scale vary between 20 and 120, and a high score indicates that the comfort is good.
|
Comfort levels of the patients were measured on the morning of the first postoperative day (before mobilisation)
|
|
Anxiety
Time Frame: postoperative day 1 before patients are mobilised
|
Measured with "State Anxiety Scale".
The state anxiety section of the state trait anxiety scale was used.
In the evaluation of the scale, all items are summed and this score is subtracted from the sum of the items marked as reversed and the number 50 is added to the result.
The result is the state anxiety score.
The total score that can be obtained from the scale is minimum 20 and maximum 80.
The increase in the score in this range indicates that the anxiety level of the individual increases.
|
postoperative day 1 before patients are mobilised
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Didem Ayhan, Associate Professor, Bandırma Onyedi Eylül University
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)
March 1, 2023
Primary Completion (Actual)
July 15, 2023
Study Completion (Actual)
July 15, 2023
Study Registration Dates
First Submitted
November 7, 2024
First Submitted That Met QC Criteria
November 12, 2024
First Posted (Estimated)
November 14, 2024
Study Record Updates
Last Update Posted (Estimated)
November 14, 2024
Last Update Submitted That Met QC Criteria
November 12, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BOEU-RSPH-BC-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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