NCT07626320

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Oct 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

June 5, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 29, 2026

Last Update Submit

June 3, 2026

Conditions

Keywords

caregiverfamily caregivercaregiver stressanxietycaregiver anxiety

Outcome Measures

Primary Outcomes (2)

  • Generalized Anxiety Disorder-7

    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

    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.

Study Arms (1)

Intervention Group

EXPERIMENTAL

Intervention Group will receive a 6-week (1-60 minute session weekly) sound bowl meditation in a community, group setting.

Other: Sound Bowl Meditation

Interventions

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.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety DisordersCaregiver Burden

Condition Hierarchy (Ancestors)

Mental DisordersStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Beth Steinberg, PhD, RN

    The Ohio State Unversity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Beth Steinberg, PhD, RN

CONTACT

Sienna Andres, BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director of Research

Study Record Dates

First Submitted

May 29, 2026

First Posted

June 4, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

June 5, 2026

Record last verified: 2026-05