Liver TransplantationNCT06085599
The Effect of Exercises on Pain and Kinesiophobia in Transplant Patients
A study testing Progressive relaxation exercises in people with Liver Transplantation, run by Gurkan KAPIKIRAN at 1 site in Turkey (Türkiye).
Trial summary
Liver transplantation is a treatment method used in acute and chronic liver failure. Progressive Relaxation Exercises, which are non-pharmacological methods aimed at minimizing complications and improving the quality of life after liver transplantation, have been reported to have many benefits such as reducing acute… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Progressive relaxation exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2022to 30 Jun 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over the age of 18 who agreed to participate in the study,
- Patients undergoing Liver Transplantation
- Patients without a disabling psychiatric disorder
Who cannot join
- Patients under the age of 18 who do not agree to participate in the study.
- Those who have a psychiatric diagnosis that prevents communication.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İnonu Üniversitesi Turgut Özal tıp Merkezi Karaciğer Nakil Enstitüsü
Malatya, 44090
About this study
Official title: The Effect of Progressive Relaxation Exercises on Pain and Kinesiophobia After Liver Transplantation
Liver transplantation is a treatment method used in acute and chronic liver failure. Progressive Relaxation Exercises, which are non-pharmacological methods aimed at minimizing complications and improving the quality of life after liver transplantation, have been reported to have many benefits such as reducing acute and chronic pain, reducing fatigue and reducing muscle tension. Therefore, in this study, the effects of progressive relaxation exercises on pain and kinesiophobia in liver transplant patients were examined.
Read the detailed description
Liver transplantation is a common treatment for acute and chronic liver failure, liver malignancy and complicated cirrhosis. Although life expectancy increases after liver transplantation, some undesirable problems such as rejection, cardiovascular risk factors, hypertension, infection and malignancy occur. Preferring non-pharmacological methods to minimise complications and improve quality of life accelerates the return of the individual to normal life. Progressive Relaxation Exercises, one of these methods, can activate the parasympathetic nervous system, blood pressure, heart and respiratory rate can be kept within clinically normal limits due to vasodilatation in the blood vessels in the peripheral area and oxygen requirement is reduced. PGE has been reported to have many benefits such as reducing the effects of anxiety and stress, reducing acute and chronic pain, nausea and vomiting, facilitating sleep, reducing fatigue, reducing respiration, blood pressure, heart rate and muscle tension. Therefore, in this study, the effects of progressive relaxation exercises on pain and kinesiophobia in liver transplant patients were examined.
- Conditions
- Liver Transplantation
- Being tested
- Progressive relaxation exercises
- Keywords
- Liver Transplantation, Progressive Relaxation Exercises, Pain, Pain level, Kinesiophobia
- Medical subject headings
- Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive relaxation exercisesBehavioural
The progressive muscle relaxation technique involves suggestive stretching and relaxation in sixteen different muscle groups of the body. This technique is based on tensing each muscle group for approximately 10 seconds and then abruptly releasing this tension.
| Study group | Role | What they receive |
|---|---|---|
| Progressive relaxation exercise group | Experimental | Sociodemographic information form, numerical pain scale and kinesiophobia scale were applied to the patients in the experimental group after liver transplantation. They were shown 15 minutes progressive relaxation exercises prepared by Mark Connelly and Jennifer Bickel on Youtube, and then the numerical pain scale and kinesiophobia scale were applied again. Receives: Behavioral: Progressive relaxation exercises |
| Control group | No intervention | No application other than clinical protocols was performed in the follow-up of the patient. In the control group, sociodemographic information form, kinesiophobia scale and numerical pain scale were applied after liver transplantation. No intervention was made. Then, the kinesiophobia scale and numerical pain scale were applied again. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level
The pain levels of the patients were measured by means of the visual pain scale.
[Time Frame: up to 24 hours post-surgery (0-1 day)]
Measured: up to 24 hours liver transplant (0-1 day
Tampa Kinesiophobia Scale (TKS)
The kinesiophobia levels of the patients were evaluated postoperatively and 24 hours after surgery.
Measured: up to 24 hours liver transplant (0-1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start30 Mar 2022
- Primary completion30 Mar 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies 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
- Model description
- This study was conducted as a randomised controlled study with experimental and control groups.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gurkan KAPIKIRAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gurkan KAPIKIRAN, Malatya Turgut Ozal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085599
- Sponsor's protocol ID
- 2021-07/21-KAEK-109
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercises on Pain and Kinesiophobia After Liver Transplantation
- ClinicalTrials.gov ID
- NCT06085599
- Acronym / sponsor ID
- 2021-07/21-KAEK-109
- Conditions
- Liver Transplantation
- Keywords
- Liver Transplantation, Progressive Relaxation Exercises, Pain, Pain level, Kinesiophobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Gurkan KAPIKIRANUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 17 Oct 2023 (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.
Liver transplantation is a treatment method used in acute and chronic liver failure. Progressive Relaxation Exercises, which are non-pharmacological methods aimed at minimizing complications and improving the quality of life after liver transplantation, have been reported to have many benefits such as reducing acute and chronic pain, reducing fatigue and reducing muscle tension. Therefore, in this study, the effects of progressive relaxation exercises on pain and kinesiophobia in liver transplant patients were examined.
Detailed description
Liver transplantation is a common treatment for acute and chronic liver failure, liver malignancy and complicated cirrhosis. Although life expectancy increases after liver transplantation, some undesirable problems such as rejection, cardiovascular risk factors, hypertension, infection and malignancy occur. Preferring non-pharmacological methods to minimise complications and improve quality of life accelerates the return of the individual to normal life. Progressive Relaxation Exercises, one of these methods, can activate the parasympathetic nervous system, blood pressure, heart and respiratory rate can be kept within clinically normal limits due to vasodilatation in the blood vessels in the peripheral area and oxygen requirement is reduced. PGE has been reported to have many benefits such as reducing the effects of anxiety and stress, reducing acute and chronic pain, nausea and vomiting, facilitating sleep, reducing fatigue, reducing respiration, blood pressure, heart rate and muscle tension. Therefore, in this study, the effects of progressive relaxation exercises on pain and kinesiophobia in liver transplant patients were examined.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study was conducted as a randomised controlled study with experimental and control groups.
| Arm | Type | Receives |
|---|---|---|
| Progressive relaxation exercise group | Experimental | Behavioral: Progressive relaxation exercisesSociodemographic information form, numerical pain scale and kinesiophobia scale were applied to the patients in the experimental group after liver transplantation. They were shown 15 minutes progressive relaxation exercises prepared by Mark Connelly and Jennifer Bickel on Youtube, and then the numerical pain scale and kinesiophobia scale were applied again. |
| Control group | No intervention | –No application other than clinical protocols was performed in the follow-up of the patient. In the control group, sociodemographic information form, kinesiophobia scale and numerical pain scale were applied after liver transplantation. No intervention was made. Then, the kinesiophobia scale and numerical pain scale were applied again. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over the age of 18 who agreed to participate in the study,
- Patients undergoing Liver Transplantation
- Patients without a disabling psychiatric disorder
Key exclusion criteria (2 listed)
- Patients under the age of 18 who do not agree to participate in the study.
- Those who have a psychiatric diagnosis that prevents communication.
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 exercisesThe progressive muscle relaxation technique involves suggestive stretching and relaxation in sixteen different muscle groups of the body. This technique is based on tensing each muscle group for approximately 10 seconds and then abruptly releasing this tension. | Behavioural | Progressive relaxation exercise group |
Primary outcome
Pain Level
Time frame: up to 24 hours liver transplant (0-1 day
The pain levels of the patients were measured by means of the visual pain scale. [Time Frame: up to 24 hours post-surgery (0-1 day)]
Tampa Kinesiophobia Scale (TKS)
Time frame: up to 24 hours liver transplant (0-1 day
The kinesiophobia levels of the patients were evaluated postoperatively and 24 hours after surgery.
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 19 Oct 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 exercises in people with Liver Transplantation, run by Gurkan KAPIKIRAN 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 3 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 19 Oct 2023. 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?
Pain Level (time frame: up to 24 hours liver transplant (0-1 day). 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 19 Oct 2023.