THE EFFECT OF RELAXATION EXERCİSE ON COMFORT AND ANXIETY IN HERNIATED LUMBAR DISC SURGERY
THE EFFECT OF PROGRESSIVE RELAXATION EXERCISES ON COMFORT AND ANXIETY LEVEL OF PATIENTS WITH LUMBAR DISC HERNIATION SURGERY: CLINICAL TRIAL
1 other identifier
interventional
42
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2023
CompletedFirst Submitted
Initial submission to the registry
November 7, 2024
CompletedFirst Posted
Study publicly available on registry
November 14, 2024
CompletedNovember 14, 2024
November 1, 2024
5 months
November 7, 2024
November 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Comfort
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
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
Study Arms (2)
progressive relaxation exercises group
EXPERIMENTALControl group
OTHERImplementation of standart postoperative care in the clinical setting.
Interventions
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.
Routine postoperative patient care in the clinic was applied.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- years of age or younger,
- With psychiatric disorders,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gemlik Muammer Ağım State Hospital
Bursa, Gemlik, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Didem Ayhan, Associate Professor
Bandırma Onyedi Eylül Üniversity
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 7, 2024
First Posted
November 14, 2024
Study Start
March 1, 2023
Primary Completion
July 15, 2023
Study Completion
July 15, 2023
Last Updated
November 14, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share