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NCT Number: NCT04346979

Telerehabilitation-based Yoga and Mindfulness Home Program in Postmenopausal Women Having Social Isolation

In the postmenopausal period when the woman spent 1/3 of her life; Due to the lack of estrogen, some physical and psychological changes occur. These changes may cause some problems. For women who perceive menopause as the first step of old age, loss of physical strength, energy, attraction and fertility, menopause can also lead to anxiety. In addition to these, they are among the emotional changes in the menopausal period in symptoms such as hypersensitivity to events, fatigue, and insomnia. Sometimes it can even be seen in psychological disorders such as melancholy and depression. The new coronavirus pneumonia (COVID-19), which appeared in Wuhan in December 2019, started to appear in different countries soon after. All countries have taken measures to prevent the spread of this virus. To this end, Turkey remains at home on March 21, 2020, and has commissioned social isolation measures. Studies investigating the effects of social isolation show that psychological and physical problems occur in individuals. Studies have shown that yoga and mindfulness programs have an impact on people's anxiety, depression, and the ability to control themselves. The purpose of this study; To investigate the effectiveness of telerehabilitation based yoga and mindfulness programs on psychological resilience, physical awareness and physical activity in postmenopausal women in social isolation due to the COVID-19 outbreak. Using telerehabilitation-based home programs aims to use an innovative model.

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Key information

Conditions

Telerehabilitation Behavior COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Social Behavior Social Isolation Virus Diseases

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istinye University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being physically or perceptually competent to exercise,
  • No spinal pathology or deformity,
  • Volunteering to participate in the study,
  • Not having menstruation for at least 12 months
  • Hormonally, surgically induced or natural menopause-confirmed women

Exclusion criteria

  • Those with serious heart disease (aortic stenosis, angina, hypertrophic cardiac myopathy, arrhythmia, pacemaker)
  • Those with inflammatory or systemic disease malignancy
  • Psychological dysfunction
  • Those who use corticosteroids

Treatment and study plan

Telerehabilitation-based

Other

25 volunteers postmenopausal women who are at home during the social isolation process due to the coronavirus outbreak will be included in this group. Online yoga and mindfulness protocol was created for individuals who will participate in the study. Each training protocol was planned as 30 minutes for 3 days a week for 6 weeks. It was planned to start the protocol with warm-up exercises and finish with cooling exercises. Respiratory exercise was added to the training protocol. Individuals were asked to participate in the study via telerehabilitation system and aimed to do their exercises with a physiotherapist.

Video-Based

Other

25 volunteers postmenopausal women who are at home during the social isolation process due to the coronavirus outbreak will be included in this group. Online yoga and mindfulness protocol was created for individuals who will participate in the study. Each training protocol was planned as 30 minutes for 3 days a week for 6 weeks. It was planned to start the protocol with warm-up exercises and finish with cooling exercises. The respiratory exercise was added to the training protocol. Video recordings containing only yoga and mindfulness training were sent to individuals. The participants were supervised by the researcher.

Primary outcomes

  1. The Brief Resilience Scale

    Time frame: 2 week

    The scale was used to measure the psychological resilience of individuals and Smith et al. (2008) were developed by. It is a 5-point Likert type, 6-item self-reporting style measurement tool. After the items in the scale and reverse coded are translated, the high scores indicate high psychological soundness.

  2. Nottingham Health Profile

    Time frame: 2 week

    Nottingham Health Profile was created in England in 1985 to evaluate the quality of life-related to health. The Nottingham Health Profile is a general quality of life questionnaire that assesses the level of individuals health problems and how they affect their daily life activities.

  3. Mindful Attention Awareness Scale

    Time frame: 2 week

    Mindful Attention Awareness Scale developed by Brown and Ryan (2003) is a 15-item scale that measures the general tendency to be aware of and be mindful of instant experiences in daily life. It has a single factor structure and gives a single total score. High scores from the scale indicate that conscious awareness is high. It is a 6-point Likert type scale.

  4. The Body Awareness Questionnaire

    Time frame: 2 week

    It is a questionnaire consisting of four subgroups (changes in body process, sleep-wake cycle, prediction at the onset of the disease, prediction of body responses) and a total of 18 expressions aimed at determining the normal or abnormal sensitivity level of the body composition. The participant is asked to score from one to seven figures for each statement. In the survey, the ratings are made as total points. A high score indicates that body sensitivity is better.

  5. Richard-Campbell Sleep Questionnaire

    Time frame: 2 week

    It, developed by Richards in 1987, is a 6-item scale that evaluates the depth of night sleep, falling asleep, frequency of waking, awakening when awakened, the quality of sleep and the level of noise in the environment. Each item is evaluated on the chart between 0 and 100 with a visual analog scale technique. "0-25" score obtained from the scale indicates very poor sleep, and the "76-100" score indicates very good sleep. Scale total score is evaluated over 5 items, and item 6 evaluating the noise level in the environment is excluded from the total score assessment. As the score of the scale increases, the sleep quality of the patients also increases.

  6. Lateral bridge test

    Time frame: 2 week

    The participant, who is on the non-dominant side, will be asked to create a support surface from the elbow with the lower arm, place the other hand on the waist, and build a bridge by lifting the hip and knee. The time that the balance is maintained will be recorded.

  7. Functional reach test

    Time frame: 2 week

    It is applied functionally both for the balance of the individual and for measuring the amount of dynamic reach. The individual is asked to lie down as long as he/she can lie down without going over the heel and hip flexion.

  8. Beck Depression Scale

    Time frame: 2 week

    It consists of 21 questions used to evaluate the emotional situation. Each question is graded between 0-3 and a high score indicates that depressive symptoms increase. 10-16 points indicate mild depressive symptoms, 17-29 points indicate moderate depressive symptoms and 30-63 points indicate severe depressive symptoms.

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study title

The Effect of Telerehabilitation Based Yoga and Mindfulness Home Program on Psychological Resilience, Body Awareness and Physical Activity in Postmenopausal Women Having Social Isolation

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 15, 2020
Registry last updated
Sep 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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