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Qigong Intervention and State Anxiety Levels of Inpatiens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06006221
Recruitment Status : Completed
First Posted : August 23, 2023
Last Update Posted : November 3, 2023
Sponsor:
Information provided by (Responsible Party):
Emel Erdeniz Güreş, Uskudar University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Psychiatric Disorder Behavioral: Qi-gong relaxation exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: The Effect of Qigong Intervention on State Anxiety Levels of Inpatiens in Psychiatric Wards: A Randomized Controlled Study
Actual Study Start Date : August 1, 2023
Actual Primary Completion Date : September 10, 2023
Actual Study Completion Date : October 2, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: experimental group
After the morning meeting, the initiative group will be given 40 minutes of Qigong relaxation exercise.
Behavioral: Qi-gong 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.

No Intervention: control group
No application will be made to the control group. The control group will continue their routine treatment in the clinic.



Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient is literate and has no communication barriers
  2. Being an inpatient in the psychiatry clinic
  3. Being over 18 years old
  4. The patient has been oriented to the service (at least 24 hours have passed since his hospitalization)
  5. Regular participation in qigong practice

Exclusion Criteria:

  1. The patient has communication difficulties
  2. Having acute psychotic symptoms
  3. Patients receiving anxiolytic therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06006221


Locations
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Turkey
Uskudar University
Istanbul, Turkey
Sponsors and Collaborators
Emel Erdeniz Güreş
Publications:
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.

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Responsible Party: Emel Erdeniz Güreş, Research Assistant, Uskudar University
ClinicalTrials.gov Identifier: NCT06006221    
Other Study ID Numbers: 0000000339492770
First Posted: August 23, 2023    Key Record Dates
Last Update Posted: November 3, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emel Erdeniz Güreş, Uskudar University:
psychiatric service,Qi Gong, nursing
Additional relevant MeSH terms:
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Mental Disorders
Problem Behavior
Behavioral Symptoms