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Qigong Intervention and State Anxiety Levels of Inpatiens

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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

Tracking Information
First Submitted Date  ICMJE August 14, 2023
First Posted Date  ICMJE August 23, 2023
Last Update Posted Date November 3, 2023
Actual Study Start Date  ICMJE August 1, 2023
Actual Primary Completion Date September 10, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2023)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Qigong Intervention and State Anxiety Levels of Inpatiens
Official Title  ICMJE The Effect of Qigong Intervention on State Anxiety Levels of Inpatiens in Psychiatric Wards: A Randomized Controlled Study
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Psychiatric Disorder
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: experimental group
    After the morning meeting, the initiative group will be given 40 minutes of Qigong relaxation exercise.
    Intervention: Behavioral: Qi-gong relaxation exercise
  • No Intervention: control group
    No application will be made to the control group. The control group will continue their routine treatment in the clinic.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2023)		 70
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2, 2023
Actual Primary Completion Date September 10, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 67 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06006221
Other Study ID Numbers  ICMJE 0000000339492770
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Emel Erdeniz Güreş, Uskudar University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Emel Erdeniz Güreş
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Uskudar University
Verification Date November 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP