- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07626320
Effectiveness of a Sound Bowl Meditation on Caregiver Stress and Anxiety
Effectiveness of a Sound Bowl Meditation on Caregiver Stress and Anxiety: A Pilot Study
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Beth Steinberg, PhD, RN
- Telefoonnummer: 614-406-7067
- E-mail: beth.steinberg@osumc.edu
Studie Contact Back-up
- Naam: Sienna Andres, BA
- Telefoonnummer: 380-283-6479
- E-mail: sienna.andres@osumc.edu
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- Professional and/or paid caregivers
- Inability to read and/or understand English (consent, study instructions, and questionnaires in English)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Intervention Group
Intervention Group will receive a 6-week (1-60 minute session weekly) sound bowl meditation in a community, group setting.
|
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 meditation will be provided by certified Sound Bowl Practitioners from the OSU Wexner Medical Center who regularly provide these interventions in the community.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Generalized Anxiety Disorder-7
Tijdsspanne: At baseline and at the end of the 6-week intervention.
|
The GAD-7 is a self-report measure of the presence and severity of anxiety symptoms over the past two weeks.
Each of the 7 questions are scored from 0 to 3; (0) "not at all", (1) "several days", (2) "more than half the days", and (3) "nearly every day".
Scale scores range from 0 to 21 with a score of 0 to 4 indicating minimal anxiety, 5 to 9 indicating mild anxiety, 10 to 14 indicating moderate anxiety, and 15 to 21 indicating severe anxiety.
|
At baseline and at the end of the 6-week intervention.
|
|
Kingston Caregiver Stress Scale
Tijdsspanne: At baseline and at end of the 6-week intervention.
|
The 10-item KCSS is a self-report measure of the perceived stress experienced by community living lay caregivers who provide day-to-day care for a family member or acquaintance.
The questions are divided into three sub-scales of stressors that include caregiving (7 questions), family issues (2 questions), and financial problems (1 question).
The measure can be used to monitor changes in stress levels over time, as caregiving situations may change.
For each of the 10 questions, the degree of stress is rated on a 1 to 5 scale that ranging from (1) Feeling Fine/No stress (Coping fine / no problems), (2) Some stress, (3) Moderate stress, (4) A lot of stress, to (5) Extreme Stress (feeling "at the end of rope", health at risk).
The total score can range from 10 to 50 with higher scores indicating higher caregiver stress.
|
At baseline and at end of the 6-week intervention.
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Beth Steinberg, PhD, RN, The Ohio State Unversity
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 20260474
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .