Psychiatric DisorderNCT06006221
Qigong Intervention and State Anxiety Levels of Inpatiens
A study testing Qi-gong relaxation exercise in people with Psychiatric Disorder, run by Emel Erdeniz Güreş at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study, which aimed to examine the effect of the Qigong relaxation exercise applied in psychiatry clinics on the level of anxiety, was planned as randomized controlled. Individuals will be divided into intervention and control groups. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Psychiatric Disorder
- What is being tested?
- Qi-gong relaxation exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 2 Oct 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 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is literate and has no communication barriers
- Being an inpatient in the psychiatry clinic
- Being over 18 years old
- The patient has been oriented to the service (at least 24 hours have passed since his hospitalization)
- Regular participation in qigong practice
Who cannot join
- The patient has communication difficulties
- Having acute psychotic symptoms
- Patients receiving anxiolytic therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Qigong Intervention on State Anxiety Levels of Inpatiens in Psychiatric Wards: A Randomized Controlled Study
The aim of the study, which aimed to examine the effect of the Qigong relaxation exercise applied in psychiatry clinics on the level of anxiety, was planned as randomized controlled. Individuals will be divided into intervention and control groups. Before the application, the Personal Information Form and STAI Form I scale will be applied to the patients in the Intervention and Control group. Patients in the intervention group are expected to answer the STAI Form I scale after qigong relaxation exercises. It planned to apply the same forms as planned in the intervention group without any application in the control group. Personal Information Form and STAI Form I Scale will be filled by the patients in the form of self-report.
Read the detailed description
Anxiety is one of the most common and compelling symptoms in individuals receiving treatment in psychiatry clinics. The issue of managing anxiety is very important in psychiatry clinics. Various pharmacological, physical, and therapeutic methods are applied to reduce and manage these symptoms. In addition to pharmacologically applied medical treatment, non-drug applications used as supportive are recommended in terms of reducing the symptoms of the disease and increasing the quality of life of the individual. These non-drug methods are; aromatherapy, physical exercise, light therapy, and music therapy. physical exercise; It is defined as planned, structured, repetitive movements to promote or maintain physical and mental health. Aerobics (brisk walking, dancing, cycling), endurance and resistance (squeezing rubber balls using elastic resistance bands and lifting weights), and flexibility and balance exercises (qigong, yoga, and pilates) are examples of physical exercises. In the literature, the effect of Qigong practices on anxiety in many patient groups has been examined, but no study has been found on the effect of Qigong relaxation exercises on the level of anxiety in inpatient psychiatric patients. Therefore, this study aims to examine the effect of Qigong relaxation exercises applied in the psychiatry clinic on the anxiety level of patients. Patients will be divided into intervention and control groups in a randomized controlled manner. After obtaining ethics committee approvals for the intervention group, clinics will be informed about the Qigong relaxation exercises study and it will be planned to place this study in the daytime program with the clinicians. The most appropriate time for patients to practice qigong relaxation exercises was determined after the morning meeting. No qigong exercise will be performed for the control group. Before the application, the Personal Information Form, STAI Form I, will be applied to the patients in the Intervention and Control group. Patients in the intervention group are expected to answer the STAI Form I scale after qigong relaxation exercises. It planned to apply the same forms as planned in the intervention group without any application in the control group. Personal Information Form and STAI Form I Scale will be filled by the patients in the form of self-report. The practice of the qigong relaxation exercise will take place after the good morning meetings. Qigong relaxation exercise is a mindfulness-based exercise and is a type of exercise consisting of body movements and relaxation in harmony with breathing used to relax the body and mind, reduce stress, distract attention from negative thoughts, accelerate blood flow, and improve emotions. It is planned to apply this exercise once for 40 minutes to the patients included in the intervention group as a group activity by researchers trained on this subject.
- Conditions
- Psychiatric Disorder
- Being tested
- Qi-gong relaxation exercise
- Keywords
- psychiatric service,Qi Gong, nursing
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qi-gong relaxation exerciseBehavioural
Qi-gong relaxation exercise is a mindfulness-based exercise and is a type of exercise that consists of breathing-compatible body movements and relaxation used to relax the body and mind, reduce stress, distract attention from negative thoughts, accelerate blood flow, and improve emotions.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | After the morning meeting, the initiative group will be given 40 minutes of Qigong relaxation exercise. Receives: Behavioral: Qi-gong relaxation exercise |
| control group | No intervention | No application will be made to the control group. The control group will continue their routine treatment in the clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
The personal information form was created by the researchers and includes demographic information and information about the disease. Demographic information consists of seven questions about age, gender, marital status, educational status, employment status, with whom she lives and whether she has a visitor in the clinic. Information about the disease; It consists of eight questions about psychiatric diagnosis, symptoms of hospitalization, duration of illness, number of hospitalizations, drugs used, whether ECT was applied, whether chemical and isolation practices were applied.
Measured: three month
STAI Anxiety Scale I
Developed by Spielberger in 1970, its Turkish version was developed by Öner N et al. The validity and reliability study was carried out by adapting it. It is a likert type scale that measures state anxiety levels with 20 questions. Anxiety level is scored as "(1) not at all, (2) a little, (3) a lot, and (4) completely" in STAI-I. Direct statements on the scale, negative emotions; reversed expressions express positive emotions. Two separate total score weights are calculated for each of the direct and reversed statements. The total score for the reverse statements is subtracted from the total score for the direct statements. A predetermined and unchanging value is added to this number. A constant value of 50 was added to the number obtained for STAI-I. The most recent value indicates the individual's anxiety score. The scores obtained from the scale range from 20 to 80. A high score indicates a high level of anxiety.
Measured: three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Aug 2023
- Primary completion10 Sep 2023
- Study completion2 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Psychiatric DisorderStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emel Erdeniz Güreş
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emel Erdeniz Güreş, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006221
- Sponsor's protocol ID
- 0000000339492770
- Status last verified
- Nov 2023
- First submitted
- 14 Aug 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan AS, Cheung MC, Sze SL, Leung WW, Shi D. Shaolin dan tian breathing fosters relaxed and attentive mind: a randomized controlled neuro-electrophysiological study. Evid Based Complement Alternat Med. 2011;2011:180704. doi: 10.1155/2011/180704. Epub 2010 Sep 22.
PubMed 20976126Abbott R, Lavretsky H. Tai Chi and Qigong for the treatment and prevention of mental disorders. Psychiatr Clin North Am. 2013 Mar;36(1):109-19. doi: 10.1016/j.psc.2013.01.011.
PubMed 23538081Wang CW, Chan CL, Ho RT, Tsang HW, Chan CH, Ng SM. The effect of qigong on depressive and anxiety symptoms: a systematic review and meta-analysis of randomized controlled trials. Evid Based Complement Alternat Med. 2013;2013:716094. doi: 10.1155/2013/716094. Epub 2013 May 20.
PubMed 23762156Wang CW, Chan CH, Ho RT, Chan JS, Ng SM, Chan CL. Managing stress and anxiety through qigong exercise in healthy adults: a systematic review and meta-analysis of randomized controlled trials. BMC Complement Altern Med. 2014 Jan 9;14:8. doi: 10.1186/1472-6882-14-8.
PubMed 24400778Chang PS, Knobf MT, Oh B, Funk M. Physical and psychological effects of Qigong exercise in community-dwelling older adults: An exploratory study. Geriatr Nurs. 2018 Jan-Feb;39(1):88-94. doi: 10.1016/j.gerinurse.2017.07.004. Epub 2017 Aug 17.
PubMed 28822591Guo Y, Xu M, Zhang J, Hu Q, Zhou Z, Wei Z, Yan J, Chen Y, Lyu J, Shao X, Wang Y, Guo J, Wei Y. The effect of Three-Circle Post Standing (Zhanzhuang) Qigong on the physical and psychological well-being of college students: Study protocol for a randomized controlled trial. Medicine (Baltimore). 2018 Sep;97(38):e12323. doi: 10.1097/MD.0000000000012323.
PubMed 30235685Oh B, Choi SM, Inamori A, Rosenthal D, Yeung A. Effects of qigong on depression: a systemic review. Evid Based Complement Alternat Med. 2013;2013:134737. doi: 10.1155/2013/134737. Epub 2013 Mar 4.
PubMed 23533461Chen CH, Hung KS, Chung YC, Yeh ML. Mind-body interactive qigong improves physical and mental aspects of quality of life in inpatients with stroke: A randomized control study. Eur J Cardiovasc Nurs. 2019 Dec;18(8):658-666. doi: 10.1177/1474515119860232. Epub 2019 Jun 23.
PubMed 31232097Xu S, Zhang D, He Q, Ma C, Ye S, Ge L, Zhang L, Liu W, Chen Z, Zhou L. Efficacy of Liuzijue Qigong in patients with chronic obstructive pulmonary disease: A systematic review and meta-analysis. Complement Ther Med. 2022 May;65:102809. doi: 10.1016/j.ctim.2022.102809. Epub 2022 Jan 29.
PubMed 35093513Molassiotis A, Vu DV, Ching SSY. The Effectiveness of Qigong in Managing a Cluster of Symptoms (Breathlessness-Fatigue-Anxiety) in Patients with Lung Cancer: A Randomized Controlled Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211008253. doi: 10.1177/15347354211008253.
PubMed 33847150Roswiyani R, Hiew CH, Witteman CLM, Satiadarma MP, Spijker J. Art activities and qigong exercise for the well-being of older adults in nursing homes in Indonesia: a randomized controlled trial. Aging Ment Health. 2020 Oct;24(10):1569-1578. doi: 10.1080/13607863.2019.1617239. Epub 2019 May 30.
PubMed 31146543Sultana M, Bryant D, Orange JB, Beedie T, Montero-Odasso M. Effect of Wii Fit(c) Exercise on Balance of Older Adults with Neurocognitive Disorders: A Meta-Analysis. J Alzheimers Dis. 2020;75(3):817-826. doi: 10.3233/JAD-191301.
PubMed 32310168Park J, Howard H, Tolea MI, Galvin JE. Perceived Benefits of Using Nonpharmacological Interventions in Older Adults With Alzheimer's Disease or Dementia With Lewy Bodies. J Gerontol Nurs. 2020 Jan 1;46(1):37-46. doi: 10.3928/00989134-20191217-01.
PubMed 31895960Özmen, E.ve Taşkın E.O., Ruhsal Hastalıklara Yönelik Tutumların Ruh Sağlığı Hizmetlerine Etkisi Stigma Ruhsal Hastalıklara Yönelik Tutumlar ve Damgalama, İzmir, 2007.
Kelleci M., Aydın D., Sabancıoğulları S., Doğan S. Hastanede Yatan Hastaların Bazı Tanı Gruplarına Göre Anksiyete ve Depresyon Düzeyleri,2009.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Qigong Intervention on State Anxiety Levels of Inpatiens in Psychiatric Wards: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06006221
- Acronym / sponsor ID
- 0000000339492770
- Conditions
- Psychiatric Disorder
- Keywords
- psychiatric service,Qi Gong, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Emel Erdeniz GüreşUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 10 Sep 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 23 Aug 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.
The aim of the study, which aimed to examine the effect of the Qigong relaxation exercise applied in psychiatry clinics on the level of anxiety, was planned as randomized controlled. Individuals will be divided into intervention and control groups. Before the application, the Personal Information Form and STAI Form I scale will be applied to the patients in the Intervention and Control group. Patients in the intervention group are expected to answer the STAI Form I scale after qigong relaxation exercises. It planned to apply the same forms as planned in the intervention group without any application in the control group. Personal Information Form and STAI Form I Scale will be filled by the patients in the form of self-report.
Detailed description
Anxiety is one of the most common and compelling symptoms in individuals receiving treatment in psychiatry clinics. The issue of managing anxiety is very important in psychiatry clinics. Various pharmacological, physical, and therapeutic methods are applied to reduce and manage these symptoms. In addition to pharmacologically applied medical treatment, non-drug applications used as supportive are recommended in terms of reducing the symptoms of the disease and increasing the quality of life of the individual. These non-drug methods are; aromatherapy, physical exercise, light therapy, and music therapy. physical exercise; It is defined as planned, structured, repetitive movements to promote or maintain physical and mental health. Aerobics (brisk walking, dancing, cycling), endurance and resistance (squeezing rubber balls using elastic resistance bands and lifting weights), and flexibility and balance exercises (qigong, yoga, and pilates) are examples of physical exercises. In the literature, the effect of Qigong practices on anxiety in many patient groups has been examined, but no study has been found on the effect of Qigong relaxation exercises on the level of anxiety in inpatient psychiatric patients. Therefore, this study aims to examine the effect of Qigong relaxation exercises applied in the psychiatry clinic on the anxiety level of patients. Patients will be divided into intervention and control groups in a randomized controlled manner. After obtaining ethics committee approvals for the intervention group, clinics will be informed about the Qigong relaxation exercises study and it will be planned to place this study in the daytime program with the clinicians. The most appropriate time for patients to practice qigong relaxation exercises was determined after the morning meeting. No qigong exercise will be performed for the control group. Before the application, the Personal Information Form, STAI Form I, will be applied to the patients in the Intervention and Control group. Patients in the intervention group are expected to answer the STAI Form I scale after qigong relaxation exercises. It planned to apply the same forms as planned in the intervention group without any application in the control group. Personal Information Form and STAI Form I Scale will be filled by the patients in the form of self-report. The practice of the qigong relaxation exercise will take place after the good morning meetings. Qigong relaxation exercise is a mindfulness-based exercise and is a type of exercise consisting of body movements and relaxation in harmony with breathing used to relax the body and mind, reduce stress, distract attention from negative thoughts, accelerate blood flow, and improve emotions. It is planned to apply this exercise once for 40 minutes to the patients included in the intervention group as a group activity by researchers trained on this subject.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: Qi-gong relaxation exerciseAfter the morning meeting, the initiative group will be given 40 minutes of Qigong relaxation exercise. |
| control group | No intervention | –No application will be made to the control group. The control group will continue their routine treatment in the clinic. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient is literate and has no communication barriers
- Being an inpatient in the psychiatry clinic
- Being over 18 years old
- The patient has been oriented to the service (at least 24 hours have passed since his hospitalization)
- Regular participation in qigong practice
Key exclusion criteria (3 listed)
- The patient has communication difficulties
- Having acute psychotic symptoms
- Patients receiving anxiolytic therapy
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 |
|---|---|---|
| Qi-gong relaxation exerciseQi-gong relaxation exercise is a mindfulness-based exercise and is a type of exercise that consists of breathing-compatible body movements and relaxation used to relax the body and mind, reduce stress, distract attention from negative thoughts, accelerate blood flow, and improve emotions. | Behavioural | experimental group |
Primary outcome
Personal Information Form
Time frame: three month
The personal information form was created by the researchers and includes demographic information and information about the disease. Demographic information consists of seven questions about age, gender, marital status, educational status, employment status, with whom she lives and whether she has a visitor in the clinic. Information about the disease; It consists of eight questions about psychiatric diagnosis, symptoms of hospitalization, duration of illness, number of hospitalizations, drugs used, whether ECT was applied, whether chemical and isolation practices were applied.
STAI Anxiety Scale I
Time frame: three month
Developed by Spielberger in 1970, its Turkish version was developed by Öner N et al. The validity and reliability study was carried out by adapting it. It is a likert type scale that measures state anxiety levels with 20 questions. Anxiety level is scored as "(1) not at all, (2) a little, (3) a lot, and (4) completely" in STAI-I. Direct statements on the scale, negative emotions; reversed expressions express positive emotions. Two separate total score weights are calculated for each of the direct and reversed statements. The total score for the reverse statements is subtracted from the total score for the direct statements. A predetermined and unchanging value is added to this number. A constant value of 50 was added to the number obtained for STAI-I. The most recent value indicates the individual's anxiety score. The scores obtained from the scale range from 20 to 80. A high score indicates a high level of anxiety.
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 3 Nov 2023.
- Background: PubMed 20976126Chan AS, Cheung MC, Sze SL, Leung WW, Shi D. Shaolin dan tian breathing fosters relaxed and attentive mind: a randomized controlled neuro-electrophysiological study. Evid Based Complement Alternat Med. 2011;2011:180704. doi: 10.1155/2011/180704. Epub 2010 Sep 22.
- Background: PubMed 23538081Abbott R, Lavretsky H. Tai Chi and Qigong for the treatment and prevention of mental disorders. Psychiatr Clin North Am. 2013 Mar;36(1):109-19. doi: 10.1016/j.psc.2013.01.011.
- Background: PubMed 23762156Wang CW, Chan CL, Ho RT, Tsang HW, Chan CH, Ng SM. The effect of qigong on depressive and anxiety symptoms: a systematic review and meta-analysis of randomized controlled trials. Evid Based Complement Alternat Med. 2013;2013:716094. doi: 10.1155/2013/716094. Epub 2013 May 20.
- Background: PubMed 24400778Wang CW, Chan CH, Ho RT, Chan JS, Ng SM, Chan CL. Managing stress and anxiety through qigong exercise in healthy adults: a systematic review and meta-analysis of randomized controlled trials. BMC Complement Altern Med. 2014 Jan 9;14:8. doi: 10.1186/1472-6882-14-8.
- Background: PubMed 28822591Chang PS, Knobf MT, Oh B, Funk M. Physical and psychological effects of Qigong exercise in community-dwelling older adults: An exploratory study. Geriatr Nurs. 2018 Jan-Feb;39(1):88-94. doi: 10.1016/j.gerinurse.2017.07.004. Epub 2017 Aug 17.
- Background: PubMed 30235685Guo Y, Xu M, Zhang J, Hu Q, Zhou Z, Wei Z, Yan J, Chen Y, Lyu J, Shao X, Wang Y, Guo J, Wei Y. The effect of Three-Circle Post Standing (Zhanzhuang) Qigong on the physical and psychological well-being of college students: Study protocol for a randomized controlled trial. Medicine (Baltimore). 2018 Sep;97(38):e12323. doi: 10.1097/MD.0000000000012323.
- Background: PubMed 23533461Oh B, Choi SM, Inamori A, Rosenthal D, Yeung A. Effects of qigong on depression: a systemic review. Evid Based Complement Alternat Med. 2013;2013:134737. doi: 10.1155/2013/134737. Epub 2013 Mar 4.
- Background: PubMed 31232097Chen CH, Hung KS, Chung YC, Yeh ML. Mind-body interactive qigong improves physical and mental aspects of quality of life in inpatients with stroke: A randomized control study. Eur J Cardiovasc Nurs. 2019 Dec;18(8):658-666. doi: 10.1177/1474515119860232. Epub 2019 Jun 23.
- Background: PubMed 35093513Xu S, Zhang D, He Q, Ma C, Ye S, Ge L, Zhang L, Liu W, Chen Z, Zhou L. Efficacy of Liuzijue Qigong in patients with chronic obstructive pulmonary disease: A systematic review and meta-analysis. Complement Ther Med. 2022 May;65:102809. doi: 10.1016/j.ctim.2022.102809. Epub 2022 Jan 29.
- Background: PubMed 33847150Molassiotis A, Vu DV, Ching SSY. The Effectiveness of Qigong in Managing a Cluster of Symptoms (Breathlessness-Fatigue-Anxiety) in Patients with Lung Cancer: A Randomized Controlled Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211008253. doi: 10.1177/15347354211008253.
- Background: PubMed 31146543Roswiyani R, Hiew CH, Witteman CLM, Satiadarma MP, Spijker J. Art activities and qigong exercise for the well-being of older adults in nursing homes in Indonesia: a randomized controlled trial. Aging Ment Health. 2020 Oct;24(10):1569-1578. doi: 10.1080/13607863.2019.1617239. Epub 2019 May 30.
- Background: PubMed 32310168Sultana M, Bryant D, Orange JB, Beedie T, Montero-Odasso M. Effect of Wii Fit(c) Exercise on Balance of Older Adults with Neurocognitive Disorders: A Meta-Analysis. J Alzheimers Dis. 2020;75(3):817-826. doi: 10.3233/JAD-191301.
- 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 Qi-gong relaxation exercise in people with Psychiatric Disorder, run by Emel Erdeniz Güreş 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 5 inclusion and 3 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 3 Nov 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?
Personal Information Form (time frame: three month). 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?
On the ClinicalTrials.gov record for NCT06006221, which also lists 18 linked publications.
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 3 Nov 2023.