Mental Health IssueNCT06297018
Bioenergy, Depression, Anxiety and Stress After Liver Transplantation
A study testing Bioenergy application in people with Mental Health Issue, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators aimed to examine the effect of bioenergy application on depression, anxiety and stress after liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Bioenergy application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 9 Feb 2024
- 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
- liver transplant recipient (ii) must be able to use immunosuppressive agents (iii) 18 years or older Liver transplant recipients
Who cannot join
- having psychiatric problems having language and communication problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Bioenergy Application
In this study, the investigators aimed to examine the effect of bioenergy application on depression, anxiety and stress after liver transplantation.
Read the detailed description
Simple random sampling method was used to assign liver recipients to experimental and control groups. Discharged liver transplant patients will be investigated for anxiety, stress and depression.
- Conditions
- Mental Health Issue
- Being tested
- Bioenergy application
- Keywords
- Biyoenergy, anxiety, stress, liver transplant recipients
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioenergy applicationBehavioural
Also called Bio fields
Bioenergy application: This group includes liver transplant recipients and recipients who underwent intervention. Depression, anxiety and stress levels are measured in the pre-test. Bioenergy is then applied. As a post-test, depression, anxiety and stress levels are measured again.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | No intervention: This group includes liver transplant recipients and no intervention is applied to this group. Depression, anxiety and stress levels are measured in the pre-test. No intervention is implemented. As a post-test, depression, anxiety and stress levels are measured again. |
| 2 | Experimental | Bioenergy group: This group includes liver transplant recipients and recipients who underwent intervention. Depression, anxiety and stress levels are measured in the pre-test. Bioenergy is then applied. As a post-test, depression, anxiety and stress levels are measured again. Receives: Behavioral: Bioenergy application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety, stress, depression: Measurement will be made with the Depression Anxiety Stress 21 Scale (DASS-21: Score range 21-63)
It will be measure Therapy on Liver Transplant Recipients'
Measured: total of six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Jan 2024
- Primary completion2 Feb 2024
- Study completion9 Feb 2024
Why it stopped: Data collect completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Interventional Crossover Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEMRA BÜLBÜLOĞLU, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297018
- Sponsor's protocol ID
- February 18, 2024
- Status last verified
- Feb 2024
- First submitted
- 18 Feb 2024
- Last updated
- 6 Mar 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bioenergy Application
- ClinicalTrials.gov ID
- NCT06297018
- Acronym / sponsor ID
- February 18, 2024
- Conditions
- Mental Health Issue
- Keywords
- Biyoenergy, anxiety, stress, liver transplant recipients
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data collect completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 6 Mar 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.
In this study, the investigators aimed to examine the effect of bioenergy application on depression, anxiety and stress after liver transplantation.
Detailed description
Simple random sampling method was used to assign liver recipients to experimental and control groups. Discharged liver transplant patients will be investigated for anxiety, stress and depression.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional Crossover Assignment
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –No intervention: This group includes liver transplant recipients and no intervention is applied to this group. Depression, anxiety and stress levels are measured in the pre-test. No intervention is implemented. As a post-test, depression, anxiety and stress levels are measured again. |
| 2 | Experimental | Behavioral: Bioenergy applicationBioenergy group: This group includes liver transplant recipients and recipients who underwent intervention. Depression, anxiety and stress levels are measured in the pre-test. Bioenergy is then applied. As a post-test, depression, anxiety and stress levels are measured again. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- liver transplant recipient (ii) must be able to use immunosuppressive agents (iii) 18 years or older Liver transplant recipients
Key exclusion criteria (1 listed)
- having psychiatric problems having language and communication problems
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 |
|---|---|---|
| Bioenergy applicationAlso: Bio fieldsBioenergy application: This group includes liver transplant recipients and recipients who underwent intervention. Depression, anxiety and stress levels are measured in the pre-test. Bioenergy is then applied. As a post-test, depression, anxiety and stress levels are measured again. | Behavioural | 2 |
Primary outcome
Anxiety, stress, depression: Measurement will be made with the Depression Anxiety Stress 21 Scale (DASS-21: Score range 21-63)
Time frame: total of six month
It will be measure Therapy on Liver Transplant Recipients'
Results and safety
The study was stopped early (reason given: Data collect completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 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.
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 Bioenergy application in people with Mental Health Issue, run by Istanbul Aydın 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 6 Mar 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 was stopped early (reason given: Data collect completed). Results are not available in the source record.
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?
Anxiety, stress, depression: Measurement will be made with the Depression Anxiety Stress 21 Scale (DASS-21: Score range 21-63) (time frame: total of six month). 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 6 Mar 2024.