Program Official

Principal Investigator

Stephanie Jean
Sohl
Awardee Organization

Wake Forest University Health Sciences
United States

Fiscal Year
2024
Activity Code
R01
Early Stage Investigator Grants (ESI)
Not Applicable
Project End Date

REmotely-delivered Supportive Programs for Improving surgical pain and disTrEss (RESPITE)

Improving the management of acute pain, psychological distress, and other surgical outcomes among women undergoing surgery for suspected gynecologic malignancies would proactively reach a population vulnerable to developing chronic pain. Non-pharmacological interventions that address multiple biobehavioral dimensions of pain (e.g., cognitive, behavioral) may be most effective at preventing the transition to chronic pain. Yoga (meditation, movements, and breathing) is a mind-body intervention that reduces pain, psychological distress, and sleep disturbances, and improves physical function. Yoga has a potential advantage over other perioperative non-pharmacological interventions because of additional components that also support multiple goals of postoperative usual care (e.g., early postoperative mobilization, encouraging deep breathing) and could help improve other surgical management outcomes (e.g., functional recovery, length of stay). Thus, yoga may optimally improve pain, psychological distress and other surgical management outcomes through multiple biobehavioral mechanisms. Yet, limited rigorous research has evaluated yoga delivered in coordination with surgical care. The proposed eHealth Mindful Movement and Breathing (eMMB) is innovative because it adapts the core components of yoga with the intention to remove key barriers to participation and mitigate the transition from acute to chronic pain. We propose to conduct a randomized controlled trial of eMMB compared to an empathic attention control (AC) among 122 women undergoing surgery for suspected gynecologic malignancies. We aim to determine the efficacy of eMMB for improving pain and other surgical outcomes (Aim 1), and to examine the effect of eMMB on proposed proximal biobehavioral outcomes (Aim 2). We will also conduct semi-structured interviews with key stakeholders (n=18-24; patients, champions, providers, yoga instructors) to assess factors that serve as barriers or facilitators to sustainably implementing eMMB in clinical care (Aim 3). Understanding these factors will inform implementation strategies to be tested in a future study. In summary, eMMB reaches patients during the perioperative period and has the potential to prevent the transition from acute to chronic pain with a low-cost intervention. The brevity and accessibility of the intervention, and the increasing popularity of yoga, make eMMB a strong candidate for future implementation. Results from this study in women undergoing surgery for gynecologic malignancies may be generalizable to other surgical procedures and thus have important public health implications for reducing the growing population affected by chronic pain. The proposed research is aligned with the scientific opportunity for mitigating long-term effects of cancer treatment highlighted by the National Cancer Institute.

Clinical Trials

Study Name Clinical Trial ID
REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss NCT05625360