ELDERLY PEOPLENCT06685731
Laughter Yoga is Role in Enhancing Sleep and Well-being in the Elderly
A study testing Laughter Yoga in people with ELDERLY PEOPLE, run by Artvin Coruh University at 1 site in Turkey (Türkiye).
Trial summary
Objective: The study aims to evaluate the effects of Laughter Yoga on sleep quality, vitality, active aging, and quality of life in individuals aged 60 and over. Method: This randomized controlled experimental study will be conducted between 01.09.2024 and 31.12.2024 with elderly individuals aged 60 and over who are… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- ELDERLY PEOPLE
- What is being tested?
- Laughter Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2024to 31 Dec 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Reside in Şavşat,
- Aged 60 or over,
- No issues with vision, hearing, or perception,
- Scored 24 or higher on the Mini-Mental State Examination,
- Not undergoing psychiatric treatment,
- No physical limitations that would impede participation in laughter yoga (e.g., fractures, open wounds, or muscle weakness in the hands, wrists, or arms),
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- Literate,
- Open to communication,
- Willing to participate in the study.
Who cannot join
- Scored below 24 on the Mini-Mental State Examination,
- Severe hearing or perceptual impairments that hinder communication,
- Major psychiatric disorders,
- Underwent surgery within the last three months,
- Medical conditions that could cause physical strain or increase abdominal pressure during laughter yoga (e.g., bleeding hemorrhoids, any type of hernia, persistent cough, severe back pain, heart disease, hypertension, urinary incontinence, epilepsy), and individuals with oncological conditions will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Mehtap Tan, Prof. Dr. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Şavşat 1St Family Health Center
Artvin, Şavşat, 08700
Şerife Köleoğlu, srfkoleoglu@gmail.com
About this study
Official title: The Effects of Laughter Yoga on Sleep Quality, Vitality, Active Aging, and Quality of Life in Elderly Individuals
Objective:
The study aims to evaluate the effects of Laughter Yoga on sleep quality, vitality, active aging, and quality of life in individuals aged 60 and over.
Read more
Method:
This randomized controlled experimental study will be conducted between 01.09.2024 and 31.12.2024 with elderly individuals aged 60 and over who are registered at Şavşat Family Health Center No. 1. The study population consists of 6,797 individuals. Participants will be randomly assigned to an experimental group (30) and a control group (30) using a simple randomization method. Data will be collected using a Personal Information Form, Mini-Mental State Examination, Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for the Elderly. The experimental group will participate in 12 Laughter Yoga sessions, conducted twice a week for 6 weeks, with each session lasting 40 minutes. No intervention will be applied to the control group. At the end of the 6th week, final measurements will be taken from both groups at the family health center.
Read the detailed description
Laughter yoga offers various approaches and insights related to humor, is low-cost, and can be easily practiced regardless of time and place, making it a highly effective and practical intervention. Research on the physiological health effects of laughter yoga has demonstrated that it enhances muscle activation, relaxes muscles, increases respiratory rate, stimulates circulation, improves oxygen saturation, reduces stress hormones (e.g., adrenaline, noradrenaline, cortisol), elevates beta-endorphin levels, alleviates pain, and enhances cognitive function. Additionally, the positive effects of humor and emotions such as happiness and optimism on psychosocial health are well-recognized. Studies on the psychosocial health outcomes of laughter yoga indicate that it reduces stress, anxiety, and depression, while improving mood, self-esteem, self-efficacy, happiness, optimism, and energy levels. Furthermore, it helps reduce interpersonal conflicts and tensions, enhances social relationships and quality of life, and boosts psychological well-being.
Although the use of laughter yoga among older adults is limited, research has shown that it has a positive impact on depression, anxiety, sleep quality, quality of life, loneliness, life satisfaction, blood pressure, and pain in this population.A review of the literature suggests that laughter yoga may be effective in improving certain physiological and psychosocial health outcomes, highlighting the need for further research.
This study aims to evaluate the effectiveness of laughter yoga in nursing practice, support its application, and investigate its potential benefits for elderly individuals. Specifically, it seeks to assess its positive impact on sleep quality, vitality, active aging, and overall quality of life, while confirming that it poses no adverse side effects for older adults.
Elderly individuals registered at the family health center will be introduced to the study and provided with detailed information regarding its objectives. Those who meet the inclusion criteria and express interest in participating will be identified. After obtaining informed consent, participants will be assigned to groups according to a randomization list. The researcher has obtained an "International Laughter Yoga Leadership Certificate" to conduct the Laughter Yoga intervention within the scope of this study.
The Personal Information Form, Mini-Mental State Examination, Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for the Elderly will be administered to both groups through face-to-face interviews conducted by the researcher (pre-test). Participants in the experimental group will be provided with comprehensive information about the Laughter Yoga intervention.
The experimental group will participate in 12 Laughter Yoga sessions, conducted twice a week over a 6-week period, with each session lasting 40 minutes. As the contagious nature of laughter facilitates easier participation when group size is larger, participants will not be divided into smaller groups during the Laughter Yoga sessions. The sessions will be led by the researcher, and their duration and frequency have been determined based on a thorough review of the relevant literature. Sessions will be held in the gymnasium of the institution where the researcher is employed, under optimal conditions. No intervention will be applied to the control group. At the end of the 6th week, participants from both groups will be invited to the family health center, where the Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for the Elderly will be administered again (post-test).
Participants in both groups will continue using their routine medications throughout the 6-week study period. Upon completion of the research, elderly individuals in the control group will be offered information on Laughter Yoga upon request.
Elderly individuals registered at the family health center will be introduced to the study and provided with detailed information regarding its objectives. Those who meet the inclusion criteria and express interest in participating will be identified. After obtaining informed consent, participants will be assigned to groups according to a randomization list. The researcher has obtained an International Laughter Yoga Leadership Certificate to conduct the Laughter Yoga intervention within the scope of this study.
The Personal Information Form, Mini-Mental State Examination, Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for the Elderly will be administered to both groups through face-to-face interviews conducted by the researcher (pre-test). Participants in the experimental group will be provided with comprehensive information about the Laughter Yoga intervention.
The experimental group will participate in 12 Laughter Yoga sessions, conducted twice a week over a 6-week period, with each session lasting 40 minutes. As the contagious nature of laughter facilitates easier participation when group size is larger, participants will not be divided into smaller groups during the Laughter Yoga sessions. The sessions will be led by the researcher, and their duration and frequency have been determined based on a thorough review of the relevant literature. Sessions will be held in the gymnasium of the institution where the researcher is employed, under optimal conditions. No intervention will be applied to the control group. At the end of the 6th week, participants from both groups will be invited to the family health center, where the Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for the Elderly will be administered again (post-test).
Participants in both groups will continue using their routine medications throughout the 6-week study period. Upon completion of the research, elderly individuals in the control group will be offered information on Laughter Yoga upon request.
- Conditions
- ELDERLY PEOPLE
- Being tested
- Laughter Yoga
- Keywords
- elderly, Laughter Yoga, Sleep Quality, Vitality, Active Aging, Elderly Quality of Life
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter YogaOther
Also called Laughter Therapy
Laughter Yoga Intervention:
Laughter Yoga is composed of four stages: deep breathing exercises, clapping and warm-up exercises, childlike play, and laughter exercises. These stages are designed to remove barriers to laughter, enhance emotional expression through childlike play, and prepare the lungs for laughter exercises.
Before the Laughter Yoga session begins, participants will be introduced to both the practice itself and to Laughter Yoga in general. The session will then proceed according to the following structure:
Deep Breathing Exercises: Participants inhale through the nose for 4-5 seconds, hold their breath for 2-3 seconds, and exhale through the mouth, with lips pursed, for one second longer than the inhalation, while smiling or laughing. This exercise is performed for 10-15 minutes.
Clapping and Warm-Up Exercises: Participants clap with palms and fingertips touching, keeping their hands parallel. This stimulates acupressure points in the hands. To increase group energy, a
| Study group | Role | What they receive |
|---|---|---|
| Participant Group | Experimental | Personal Information Form, Mini-Mental State Examination, Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for Elderly Individuals will be administered to elderly individuals via face-to-face interviews conducted by the researcher.
Elderly individuals will be provided with information about the Laughter Yoga sessions.
The elderly participants will undergo a total of 12 Laughter Yoga sessions, with each session lasting 40 minutes, conducted twice a week for 6 weeks.
Participants' phone numbers will be collected, and they will be contacted twice a week to ensure their attendance at the Laughter Yoga sessions. Receives: Other: Laughter Yoga |
| Control group | No intervention | Personal Information Form, Mini-Mental State Examination, Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for the Elderly will be administered to elderly individuals through face-to-face interviews conducted by the researcher. No intervention will be applied to the elderly individuals in this group. Phone numbers of the participants in this group will be collected, and they will be contacted once a week to check on their status. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-test
Mini Mental State Test (MMST): Assesses cognitive function on a 0-30 scale; higher scores indicate better cognitive function. The score will be reported independently.
Measured: Initial enrollment in the study
Secondary outcomes (4)
Active Aging Scale
Scores range from 0 to 272 across four subscales, with higher scores indicating greater active aging. This score is reported as a separate outcome.
Measured: From enrollment to the end of treatment at 6 weeks
Pittsburgh Sleep Quality Index (PSQI)
Measures sleep quality, where scores of 5 or more indicate poor sleep quality. PSQI results are reported separately.
Measured: From enrollment to the end of treatment at 6 weeks
Subjective Vitality Scale (SVS)
Ranges from 7 to 49, with higher scores reflecting higher vitality. It is reported as an independent measure of vitality.
Measured: From enrollment to the end of treatment at 6 weeks
CASP-13 Quality of Life Scale
Evaluates quality of life in terms of autonomy and satisfaction, with higher scores indicating better life quality, and will be reported separately.
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start5 Sep 2024
- Primary completion9 Sep 2024
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ELDERLY PEOPLEStudies 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artvin Coruh University
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Principal investigator, Şerife Köleoğlu, Artvin Coruh University
- Investigators
- Mehtap Tan, Prof. Dr., Study director, Atatürk Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685731
- Sponsor's protocol ID
- Artvin Çoruh Universty
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 12 Nov 2024
- 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 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Laughter Yoga on Sleep Quality, Vitality, Active Aging, and Quality of Life in Elderly Individuals
- ClinicalTrials.gov ID
- NCT06685731
- Acronym / sponsor ID
- Artvin Çoruh Universty
- Conditions
- ELDERLY PEOPLE
- Keywords
- elderly, Laughter Yoga, Sleep Quality, Vitality, Active Aging, Elderly Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Artvin Coruh UniversityUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 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.
Objective:
The study aims to evaluate the effects of Laughter Yoga on sleep quality, vitality, active aging, and quality of life in individuals aged 60 and over.
Method:
This randomized controlled experimental study will be conducted between 01.09.2024 and 31.12.2024 with elderly individuals aged 60 and over who are registered at Şavşat Family Health Center No. 1. The study population consists of 6,797 individuals. Participants will be randomly assigned to an experimental group (30) and a control group (30) using a simple randomization method. Data will be collected using a Personal Information Form, Mini-Mental State Examination, Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for the Elderly. The experimental group will participate in 12 Laughter Yoga sessions, conducted twice a week for 6 weeks, with each session lasting 40 minutes. No intervention will be applied to the control group. At the end of the 6th week, final measurements will be taken from both groups at the family health center.
Detailed description
Laughter yoga offers various approaches and insights related to humor, is low-cost, and can be easily practiced regardless of time and place, making it a highly effective and practical intervention. Research on the physiological health effects of laughter yoga has demonstrated that it enhances muscle activation, relaxes muscles, increases respiratory rate, stimulates circulation, improves oxygen saturation, reduces stress hormones (e.g., adrenaline, noradrenaline, cortisol), elevates beta-endorphin levels, alleviates pain, and enhances cognitive function. Additionally, the positive effects of humor and emotions such as happiness and optimism on psychosocial health are well-recognized. Studies on the psychosocial health outcomes of laughter yoga indicate that it reduces stress, anxiety, and depression, while improving mood, self-esteem, self-efficacy, happiness, optimism, and energy levels. Furthermore, it helps reduce interpersonal conflicts and tensions, enhances social relationships and quality of life, and boosts psychological well-being.
Although the use of laughter yoga among older adults is limited, research has shown that it has a positive impact on depression, anxiety, sleep quality, quality of life, loneliness, life satisfaction, blood pressure, and pain in this population.A review of the literature suggests that laughter yoga may be effective in improving certain physiological and psychosocial health outcomes, highlighting the need for further research.
This study aims to evaluate the effectiveness of laughter yoga in nursing practice, support its application, and investigate its potential benefits for elderly individuals. Specifically, it seeks to assess its positive impact on sleep quality, vitality, active aging, and overall quality of life, while confirming that it poses no adverse side effects for older adults.
Elderly individuals registered at the family health center will be introduced to the study and provided with detailed information regarding its objectives. Those who meet the inclusion criteria and express interest in participating will be identified. After obtaining informed consent, participants will be assigned to groups according to a randomization list. The researcher has obtained an "International Laughter Yoga Leadership Certificate" to conduct the Laughter Yoga intervention within the scope of this study.
The Personal Information Form, Mini-Mental State Examination, Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for the Elderly will be administered to both groups through face-to-face interviews conducted by the researcher (pre-test). Participants in the experimental group will be provided with comprehensive information about the Laughter Yoga intervention.
The experimental group will participate in 12 Laughter Yoga sessions, conducted twice a week over a 6-week period, with each session lasting 40 minutes. As the contagious nature of laughter facilitates easier participation when group size is larger, participants will not be divided into smaller groups during the Laughter Yoga sessions. The sessions will be led by the researcher, and their duration and frequency have been determined based on a thorough review of the relevant literature. Sessions will be held in the gymnasium of the institution where the researcher is employed, under optimal conditions. No intervention will be applied to the control group. At the end of the 6th week, participants from both groups will be invited to the family health center, where the Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for the Elderly will be administered again (post-test).
Participants in both groups will continue using their routine medications throughout the 6-week study period. Upon completion of the research, elderly individuals in the control group will be offered information on Laughter Yoga upon request.
Elderly individuals registered at the family health center will be introduced to the study and provided with detailed information regarding its objectives. Those who meet the inclusion criteria and express interest in participating will be identified. After obtaining informed consent, participants will be assigned to groups according to a randomization list. The researcher has obtained an International Laughter Yoga Leadership Certificate to conduct the Laughter Yoga intervention within the scope of this study.
The Personal Information Form, Mini-Mental State Examination, Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for the Elderly will be administered to both groups through face-to-face interviews conducted by the researcher (pre-test). Participants in the experimental group will be provided with comprehensive information about the Laughter Yoga intervention.
The experimental group will participate in 12 Laughter Yoga sessions, conducted twice a week over a 6-week period, with each session lasting 40 minutes. As the contagious nature of laughter facilitates easier participation when group size is larger, participants will not be divided into smaller groups during the Laughter Yoga sessions. The sessions will be led by the researcher, and their duration and frequency have been determined based on a thorough review of the relevant literature. Sessions will be held in the gymnasium of the institution where the researcher is employed, under optimal conditions. No intervention will be applied to the control group. At the end of the 6th week, participants from both groups will be invited to the family health center, where the Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for the Elderly will be administered again (post-test).
Participants in both groups will continue using their routine medications throughout the 6-week study period. Upon completion of the research, elderly individuals in the control group will be offered information on Laughter Yoga upon request.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participant Group | Experimental | Other: Laughter YogaPersonal Information Form, Mini-Mental State Examination, Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for Elderly Individuals will be administered to elderly individuals via face-to-face interviews conducted by the researcher. Elderly individuals will be provided with information about the Laughter Yoga sessions. The elderly participants will undergo a total of 12 Laughter Yoga sessions, with each session lasting 40 minutes, conducted twice a week for 6 weeks. Participants' phone numbers will be collected, and they will be contacted twice a week to ensure their attendance at the Laughter Yoga sessions. |
| Control group | No intervention | –Personal Information Form, Mini-Mental State Examination, Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for the Elderly will be administered to elderly individuals through face-to-face interviews conducted by the researcher. No intervention will be applied to the elderly individuals in this group. Phone numbers of the participants in this group will be collected, and they will be contacted once a week to check on their status. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Reside in Şavşat,
- Aged 60 or over,
- No issues with vision, hearing, or perception,
- Scored 24 or higher on the Mini-Mental State Examination,
- Not undergoing psychiatric treatment,
Key exclusion criteria (5 listed)
- Scored below 24 on the Mini-Mental State Examination,
- Severe hearing or perceptual impairments that hinder communication,
- Major psychiatric disorders,
- Underwent surgery within the last three months,
- Medical conditions that could cause physical strain or increase abdominal pressure during laughter yoga (e.g., bleeding hemorrhoids, any type of hernia, persistent cough, severe back pain, heart disease, hypertension, urinary incontinence, epilepsy), and individuals with oncological conditions will be excluded from the study.
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 |
|---|---|---|
| Laughter YogaAlso: Laughter TherapyLaughter Yoga Intervention: Laughter Yoga is composed of four stages: deep breathing exercises, clapping and warm-up exercises, childlike play, and laughter exercises. These stages are designed to remove barriers to laughter, enhance emotional expression through childlike play, and prepare the lungs for laughter exercises. Before the Laughter Yoga session begins, participants will be introduced to both the practice itself and to Laughter Yoga in general. The session will then proceed according to the following structure: Deep Breathing Exercises: Participants inhale through the nose for 4-5 seconds, hold their breath for 2-3 seconds, and exhale through the mouth, with lips pursed, for one second longer than the inhalation, while smiling or laughing. This exercise is performed for 10-15 minutes. Clapping and Warm-Up Exercises: Participants clap with palms and fingertips touching, keeping their hands parallel. This stimulates acupressure points in the hands. To increase group energy, a | Other | Participant Group |
Primary outcome
Pre-test
Time frame: Initial enrollment in the study
Mini Mental State Test (MMST): Assesses cognitive function on a 0-30 scale; higher scores indicate better cognitive function. The score will be reported independently.
4 secondary outcomes
Active Aging Scale
Time frame: From enrollment to the end of treatment at 6 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: From enrollment to the end of treatment at 6 weeks
Subjective Vitality Scale (SVS)
Time frame: From enrollment to the end of treatment at 6 weeks
CASP-13 Quality of Life Scale
Time frame: From enrollment to the end of treatment at 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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.
Mehtap Tan, Prof. Dr. contact
Mehtap Tan, Prof. Dr. study director
Atatürk Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laughter Yoga in people with ELDERLY PEOPLE, run by Artvin Coruh 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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Şerife Köleoğlu (+90 506 243 26 07, srfkoleoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-test (time frame: Initial enrollment in the study). 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 12 Nov 2024.