- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07430176
The Effects of Benson and Progressive Relaxation Techniques on Pain and Sleep in Lobectomy.
THE EFFECT OF BENSON AND PROGRESSİVE RELAXATİON TECHNİQUES ON PAİN AND SLEEP QUALİTY İN LOBECTOMY PATİENS
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Çağla toprak TOPRAK, PHD
- Phone Number: 0090 532 799 78 14
- Email: cagla.toprak@atlas.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 18 and over, Patients undergoing planned lobectomy surgery for the first time, Patients without diagnosed sleep problems, Patients who volunteer to participate in the study, Patients whose cognitive level is suitable for progressive relaxation and Benson exercises, Patients without visual, hearing, or speech problems will be included in the study.
Exclusion Criteria:
- Patients with mental health issues, those who are not volunteers to participate in the study, and patients undergoing emergency surgery will not be included.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Benson Relaxation Group
Benson Relaxation Exercise Instructions Choose a word or short phrase that is meaningful to you and will allow you to focus your attention (Example: Love, affection, God, health). Sit in a comfortable position. Close your eyes. Relax all your muscles (calf, thigh, abdomen, chest, shoulder, neck, and head), starting from your feet and moving upwards to your muscle groups. Breathe slowly and naturally. As you exhale, silently say the chosen word or phrase to yourself. Maintain a passive attitude. Do not worry about whether you are doing well or not. If disturbing thoughts come to your mind, ignore them and say to yourself, "Everything is very good," "I am healthy and fit," and focus on your breath and muscles. Focus on relaxing and calming down until the instructions are finished. When the instructions are finished, do not stand up immediately. Sit quietly for a minute or two so you can return to your current environment. Then slowly open your eyes and sit for another minute or two. |
Now, find the most comfortable position for yourself in the chair you're sitting in and close your eyes.
Feel the rhythm of your breathing.
Breathe in through your nose and exhale slowly and easily through your mouth.
Notice how your body relaxes a little more with each exhale.
Focus your attention on what I'm saying.
When other thoughts come to mind, refocus your attention on what I'm saying.
Now, let your arms hang down at your sides and, while breathing in, clench your fists and tense your hand muscles… Clench your fists and hold like that for a little while.
Now open your fists and allow your hands to relax.
Try to notice how relaxed your hand muscles are and how they are starting to warm up.
Now take a deep breath and hold it in your chest.
Notice how the muscles in your chest tense up, keep your muscles tense and release.
|
|
Experimental: Progressive muscle relaxation group
Now, find the most comfortable position for yourself in the chair you're sitting in and close your eyes. Feel the rhythm of your breathing. Breathe in through your nose and exhale slowly and easily through your mouth. Notice how your body relaxes a little more with each exhale. Focus your attention on what I'm saying. When other thoughts come to mind, refocus your attention on what I'm saying. Now, let your arms hang down at your sides and, while breathing in, clench your fists and tense your hand muscles… Clench your fists and hold like that for a while. Now open your fists and allow your hands to relax. Try to notice how relaxed your hand muscles are and how they are starting to warm up. Now take a deep breath and hold it in your chest. Notice how the muscles in your chest tense up, keep your muscles tense and release. Continue to breathe deeply and comfortably… Feel your chest muscles release their tension and relax." "Now, tense the muscles in your legs. Notice how these muscles |
Now, find the most comfortable position for yourself in the chair you're sitting in and close your eyes.
Feel the rhythm of your breathing.
Breathe in through your nose and exhale slowly and easily through your mouth.
Notice how your body relaxes a little more with each exhale.
Focus your attention on what I'm saying.
When other thoughts come to mind, refocus your attention on what I'm saying.
Now, let your arms hang down at your sides and, while breathing in, clench your fists and tense your hand muscles… Clench your fists and hold like that for a little while.
Now open your fists and allow your hands to relax.
Try to notice how relaxed your hand muscles are and how they are starting to warm up.
Now take a deep breath and hold it in your chest.
Notice how the muscles in your chest tense up, keep your muscles tense and release.
|
|
No Intervention: Control Group
No attempt was made.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
THE VİSUAL ANALOG SCALA
Time Frame: Days 1 and 2 after surgery
|
The Visual Analog Scale (VAS) is a one-dimensional scale commonly used to measure pain intensity.
The VAS is a measuring instrument that is 0-10 cm (0-100 mm) long.
This measuring instrument can be used horizontally or vertically.
The scale starts with "no pain" and ends with "unbearable pain".
High scores on the scale indicate high pain intensity.
The cutoff points for pain scores obtained from the scale are suggested as 0-4 mm "no pain", 5-44 mm "mild pain", 45-74 mm "moderate pain" and 75-100 mm "severe pain" (103).
In our study, the VAS scale will be used horizontally and in cm to measure the pain intensity, anxiety and comfort levels of the patients.
|
Days 1 and 2 after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Richard-Campbell Sleep Scale
Time Frame: Day 1, 2 after surgery
|
Developed by Richard in 1987, the RCSQ (Richard's Clinical Sleep Quality Scale) consists of six questions in total and is evaluated using a scale based on a score between 0 and 100.
The first question measures sleep depth, difficulty falling asleep, frequency of nighttime awakenings, returning to sleep, overall sleep quality, and environmental noise levels.
Scores obtained from the scale are evaluated as follows: scores between 0 and 25 indicate poor sleep quality, and scores between 76 and 100 indicate good sleep quality.
It has been observed that as the scores obtained from the scale increase, sleep quality also improves.
|
Day 1, 2 after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 31.07.2025
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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