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Набор скоро начнётся NCT07626320

Effectiveness of a Sound Bowl Meditation on Caregiver Stress and Anxiety

Без фазы С лечением Stress Anxiety

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Sound Bowl Meditation.
Кому может быть актуально
Состояния в реестре: Stress, Anxiety. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effectiveness of a Sound Bowl Meditation on Caregiver Stress and Anxiety: A Pilot Study

Обзор

Being a primary caregiver for a family member or friend can be physically and emotionally demanding leaving little time for the unpaid caregiver's professional pursuits, personal appointments, and self-care. Primary caregivers are often overwhelmed, and experience stress, anxiety, depression, and sleep disturbances. Passive activities that require no physical or mental exertion may provide support and can help improve overall well-being. Sounds from crystal sound bowls and other instruments combined with guided meditations have been found to promote relaxation and to reduce stress and anxiety. Participants can sit in a chair or lie on a yoga mat, supported by pillows and blankets, to enhance comfort and rest. Eye masks can also be used to minimize light and promote peacefulness. The purpose of this study is to assess if a weekly Sound Bowl Meditation, offered over the course of 6 weeks and provided by a certified Sound Bowl practitioner, can help decrease caregiver stress and anxiety related to the role as a primary caregiver.

Подробное описание

Over the past 10 years, the number of adults who provide essential in-home care for family members has increased by 50%. These family caregivers are often spouses or partners, adult children, siblings, parents, or other individuals within the patient's social network. Currently in the U.S., more than 42 million family members serve as primary caregivers for chronically ill and/or disabled adults or children, providing all physical care, symptom management, and psychosocial support. With little to no formal training, almost half of these family caregivers provide high-intensity medical care that involves complex medication administration, patient transfers and mobility assistance, and management of medical equipment. As the aging U.S. population increases, more individuals will need care and assistance while rising healthcare costs will make professional care, offered at home or within a facility, less accessible and less affordable. While education and skills training related to management of the family member's medical needs and safety for the caregiver are essential, regular interventions that can improve resilience, provide intellectual stimulation, promote social connection and relaxation are necessary to counter the negative effects of caregiving.

Sound medicine is a relatively new name for sound interventions that can elicit happiness, contentment, and relaxation. Sound interventions encompass musical and non-musical sounds, such as nature sounds and calming voices. Exposure to these sounds have shown reduced stress and improved well-being. Sound healing has been in existence for centuries and has been used in a variety of cultures as an integral part of life events and celebrations. While any instruments that produce a beat or melody can be used in sound healing, sound bowls, also called singing bowls, can produce frequencies that resonate within the human body to promote deep relaxation and an improved sense of well-being. Although the mechanism of effect is not well understood, the binaural beats and vibrations emitted by the sound bowls may interact with the energy field surrounding the human body. The beat frequency of the sound bowls mirrors the theta wave region of the brain which increases in the relaxed meditation state. The facilitation of more meditative state through exposure to sound bowl interventions has shown improvements in anxiety, depression, fatigue, and mood, as well as physiological improvements in blood pressure, heart rate, respiratory rate, peripheral oxygen saturation and positive electroencephalographic changes.

Supportive interventions for family caregivers should optimally provide brief periods of respite without requiring physical or mental exertion to perform. Participating or receiving a sound bowl intervention is passive and has no reported negative side effects. Given the gap in the literature related to the effects of sound bowl interventions for family caregivers, and the physical, mental, and emotional stressors inherent in the caregiving role, the evaluation of benefits for this low cost, low technology invention is practical and needed.

The purpose of this pilot study is to evaluate the effectiveness of a 6-week sound bowl meditation intervention on caregiver perceived stress and anxiety. Results from this pilot study will be used to assess feasibility of the study protocol and inform a future, larger study.

Due to the prevalence of caregiver perceived stress and anxiety, the investigators hypothesize that a sound bowl meditation intervention, offered weekly over the course of 6 weeks, will reduce caregiver perceived stress and anxiety.

Вмешательства

  • Другое Sound Bowl Meditation
    The study intervention is a sound bowl meditation, offered weekly (same day and same time of day) for six weeks; each session will be 60 minutes in length. The sound bowl meditation will include the use of a Reem drum, Tingsha bells (small cymbals used to induce relaxation, reduce stress, and restore energetic balance), and eight crystal sound bowls. Participants will be fully clothed and will be able to sit in a chair or lie on a yoga mat with yoga props used for comfort. The sound bowl meditat

Первичные конечные точки

  • Generalized Anxiety Disorder-7 [Срок оценки: At baseline and at the end of the 6-week intervention.]
  • Kingston Caregiver Stress Scale [Срок оценки: At baseline and at end of the 6-week intervention.]

Критерии участия

Критерии включения

  • Adults age 18 years and older
  • Primary, unpaid caregiver of a family member (spouse, sibling, parent, child, etc.) or an unrelated adult (friend) who is chronically ill and/or disabled
  • Primary, unpaid caregiver has provided care to family member or an unrelated adult for a minimum of six months
  • Normal hearing capacity with or without corrective hearing aids
  • Availability and willingness to participate in the six week sound bowl meditation intervention
  • Access to a smartphone or personal electronic tablet with adequate WiFi access and a personal email
  • Willingness and ability to download the MyCap app to complete study surveys

Критерии исключения

  • Professional and/or paid caregivers
  • Inability to read and/or understand English (consent, study instructions, and questionnaires in English)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07626320 · 20260474

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗