NCT06546956

Integrative Breathwork Intervention for Chronic Pain

Developing and Testing a Multicomponent Breathwork Intervention for Adults With Chronic Pain

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The proposed research is to develop and refine a multicomponent breathwork intervention, Guided Respiration Mindfulness Therapy, and to iteratively evaluate its feasibility, acceptability, and plausibility for clinically significant effects in people with chronic low back pain. This integrative breathwork intervention involves a 60-minute breathing session where the focus is to maintain a conscious connected breathing pattern (no pause between inhale and exhale), apply mindful acceptance to somatic sensations, and relax any physical tension. Each breathwork session will be delivered 1-on-1 in person by a trained facilitator. The treatment consists of 8 breathwork sessions, once per week for 8 weeks.

Detailed description

Multiple single-arm iterations of an 8-week breathwork intervention will be conducted to refine and optimize the intervention and protocol. Upon completion of each iteration, quantitative and qualitative data will be gathered to identify possible modifications before proceeding with the next iteration. This work will provide initial evidence on the feasibility, acceptability, and plausibility of clinically significant effects of this type of multicomponent breathwork intervention for adults with chronic low back pain.

Conditions

• Chronic Low-back Pain

Interventions

Type	Name	Description
BEHAVIORAL	Integrative Breathwork Intervention	GRMT has three core components: respiratory regulation (i.e., sustained conscious connected breathing pattern into the upper chest where there is no pause between inhale and exhale), mindfulness of somatic sensations while breathing (i.e., interoceptive awareness with acceptance), and relaxation of physical tension. These components are the primary focus in every breathwork session. The intervention is delivered 1-on-1 in-person with a trained facilitator. Participants lay supine throughout the 60 minute session. The facilitator observes the participant's breathing pattern and guides the participant to apply the three core components. Each session ends with spontaneous, relaxed breathing and an opportunity to briefly share what happened during the session.

Timeline

• Start date: 2024-10-24
• Primary completion: 2025-12-10
• Completion: 2026-01-09
• First posted: 2024-08-09
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States