Lumbar Disc HerniationNCT06688773
THE EFFECT OF RELAXATION EXERCİSE ON COMFORT AND ANXIETY IN HERNIATED LUMBAR DISC SURGERY
A study testing Progressive relaxation exercise in people with Lumbar Disc Herniation, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Progressive relaxation exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 15 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 18 years of age or younger,
- With psychiatric disorders,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gemlik Muammer Ağım State Hospital
Bursa, Gemlik
About this study
Official title: 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.
Read the 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.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Progressive relaxation exercise, Control group: Standart nursing care group
- Keywords
- Anxiety, comfort level, nursing, lumbar disc herniation, progressive relaxation exercises
- Medical subject headings
- Intervertebral Disc Displacement, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive relaxation exerciseBehavioural
Also called PGE
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.
Control group: Standart nursing care groupOther
Routine postoperative patient care in the clinic was applied.
| Study group | Role | What they receive |
|---|---|---|
| progressive relaxation exercises group | Experimental | Not described Receives: Behavioral: Progressive relaxation exercise |
| Control group | Other | Implementation of standart postoperative care in the clinical setting. Receives: Other: Control group: Standart nursing care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: postoperative day 1 before patients are mobilised
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start1 Mar 2023
- Primary completion15 Jul 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didem Ayhan, Bandırma Onyedi Eylül University
- Investigators
- Didem Ayhan, Associate Professor, Study director, Bandırma Onyedi Eylül Üniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688773
- Sponsor's protocol ID
- BOEU-RSPH-BC-01
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF PROGRESSIVE RELAXATION EXERCISES ON COMFORT AND ANXIETY LEVEL OF PATIENTS WITH LUMBAR DISC HERNIATION SURGERY: CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT06688773
- Acronym / sponsor ID
- BOEU-RSPH-BC-01
- Conditions
- Lumbar Disc Herniation
- Keywords
- Anxiety, comfort level, nursing, lumbar disc herniation, progressive relaxation exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| progressive relaxation exercises group | Experimental | Behavioral: Progressive relaxation exercise |
| Control group | Other | Other: Control group: Standart nursing care groupImplementation of standart postoperative care in the clinical setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (2 listed)
- 18 years of age or younger,
- With psychiatric disorders,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive relaxation exerciseAlso: PGEIn 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. | Behavioural | progressive relaxation exercises group |
| Control group: Standart nursing care groupRoutine postoperative patient care in the clinic was applied. | Other | Control group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didem Ayhan, Associate Professor study director
Bandırma Onyedi Eylül Üniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive relaxation exercise in people with Lumbar Disc Herniation, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort (time frame: Comfort levels of the patients were measured on the morning of the first postoperative day (before mobilisation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.