- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06006221
Qigong Intervention and State Anxiety Levels of Inpatiens
November 1, 2023 updated by: Emel Erdeniz Güreş
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey
- Uskudar University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- The patient has communication difficulties
- Having acute psychotic symptoms
- Patients receiving anxiolytic therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
After the morning meeting, the initiative group will be given 40 minutes of Qigong relaxation exercise.
|
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.
|
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No Intervention: control group
No application will be made to the control group.
The control group will continue their routine treatment in the clinic.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
three month
|
|
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.
|
three month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Abbott 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.
- 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.
- Wang 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.
- Wang 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.
- Chang 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.
- Guo 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.
- Oh 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.
- Chen 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.
- Xu 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.
- Molassiotis 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.
- Roswiyani 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.
- Sultana 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.
- Park 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.
- Özmen, 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.
- Kurt E. M., Kannabis kullanım bozukluğu hastalarında gastrointestinal sistem (GİS) hormonları ile agresyon ve aşerme arasındaki İlişkinin İncelenmesi, Uzmanlık Tezi Sakarya Üniversitesi, 2020.
- Savaşan, A., ve Mete, L. (2018). Bir eğitim ve araştırma hastanesi psikiyatri kliniklerinde agresyonun ve kısıtlama yöntemlerinin incelenmesi. Klinik Psikiyatri Dergisi, 21(2), 130-136.
- Şahin M., Korku, Kaygı ve Kaygı (Anksiyete) Bozuklukları, Avrasya Sosyal ve Ekonomi Araştırmaları Dergisi, Cilt 6. Sayı S 117-135,2019.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2023
Primary Completion (Actual)
September 10, 2023
Study Completion (Actual)
October 2, 2023
Study Registration Dates
First Submitted
August 14, 2023
First Submitted That Met QC Criteria
August 21, 2023
First Posted (Actual)
August 23, 2023
Study Record Updates
Last Update Posted (Estimated)
November 3, 2023
Last Update Submitted That Met QC Criteria
November 1, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0000000339492770
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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