University of Washington, School of Medicine
Seattle, Washington, 98104, United States
NCT Number: NCT06050083
This ClinicalTrials.gov posting contains two randomized controlled trials. The study procedures were identical, except Study 1 was funded by NIH and enrolled adults with chronic low back pain, whereas Study 2 was funded by the UW Department of Rehabilitation Medicine and enrolled adults with any type of chronic pain. Study 1 and 2 each enrolled 50 adults (N = 100 total across the two studies). Although Study 2 did not use NIH funds, we are including the results here because the studies were conducted simultaneously by the same PI (Dr. Jensen) with the same study procedures.
Participants enrolled in the studies for a duration of 8 weeks. The studies test the feasibility and efficacy of a therapeutic hypnosis digital application (website), called Rose. The investigators wanted to determine if the Rose application was user-friendly and effective at improving quality of life and reducing pain for adults with chronic pain. If successfuly, the investigators hope to develop the Rose application into a mobile app that will be publicly available and managed by HypnoScientific Inc., a company that is co-owned by the investigators.
Participants completed brief (15-20min) self-report surveys that ask about pain and mental health at three timepoints: Baseline (week 0), 4 weeks, and 8 weeks.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Seattle, Washington, 98104, United States
Pain is a major public health problem that affects over 100 million adults in the United States. While pain can have profound negative impacts, current treatment remains inadequate. A focus on opioid treatments has led to over-prescription, harmful side effects, and the overuse crisis. To address this problem, the study investigators, and others, have developed and adapted hypnosis to empower individuals to self-manage pain. Findings from the investigators' research supports hypnosis as an effective non-pharmacological technique. However, a significant limitation of hypnosis treatment is access, given that hypnosis treatment is provided by a very limited number of clinicians with training in its use, as well as the significant costs of in-person treatment.
The main goal of this study is to pilot test the efficacy of hypnosis content for pain management as provided via recordings in the Rose web application.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(self-report online and telephone screening by study staff):
Exclusion criteria
A web application (Rose) that contains hypnosis audio recordings created by the investigators.
Time frame: During the 8 weeks of study participation
Total # of hypnosis sessions listened to by participants
Time frame: 8 week assessment
Participants reporting how interested they would be in continuing to use the Rose application: "If the Rose web/phone application were available to download, how interested would you be in downloading and using this application?" 4 - Extremely interested 3 - Very interested 2 - Somewhat interested
1 - Little interested 0 - Not interested
Time frame: 8 week assessment
Participants that reported a willingness to pay for continued access to the Rose application (results available for Study 2 only): "Would you be willing to pay some amount for a monthly subscription to Rose, to have continued access?"
1 - Yes 0 - No
Time frame: 4 Week, 8 Week timepoints
Participants answered a Global Satisfaction question about their satisfaction with using the Rose application "Taking all things into account, how satisfied are you with using the Rose web application?" 4 - Very Satisfied 3 - Somewhat Satisfied 2 - Neutral
1 - Somewhat Dissatisfied 0 - Very Dissatisfied
Time frame: 8 Week Timepoint
Scale title: System Usability Scale. Minimum - Maximum range: 0 to 100. Higher scores indicate more usability (ease of use). There are no subscale scores for this measure.
Time frame: Baseline, 4 Weeks, 8 Weeks
A 0-10 Numerical Rating scale of average pain in the past week: "Please rate your pain by choosing the one number that best describes your pain at its WORST in the PAST WEEK, where 0 is "no pain" and 10 is "pain as bad as you can imagine"
Time frame: Baseline, 4 Weeks, 8 Weeks
A 0-10 Numerical Rating scale of worst pain in the past week: "Please rate your pain by choosing the one number that best describes your pain at its WORST in the PAST WEEK, where 0 is "no pain" and 10 is "pain as bad as you can imagine"
Time frame: Baseline (week 0), 4 week assessment, 8 week assessment
Domain assessed: Sleep Disturbance. Ratings are summed and converted to T scores (Mean = 50 and SD = 10 in the normative sample).
Higher scores indicate more sleep disturbance. Scores that are >= 55 (i.e., one half a SD above the normative mean) are considered clinically elevated.
Time frame: Baseline (week 0), 4 week assessment, 8 week assessment
Domain assessed: Pain interference. Ratings are summed and converted to T scores (Mean = 50 and SD = 10 in the normative sample).
Higher scores indicate more pain interference. Scores that are >= 55 (i.e., one half a SD above the normative mean) are considered clinically elevated.
Time frame: Baseline (week 0), 4 week assessment, 8 week assessment
Domain assessed: Anxiety. Ratings are summed and converted to T scores (Mean = 50 and SD = 10 in the normative sample).
Higher scores indicate more anxiety. Scores that are >= 55 (i.e., one half a SD above the normative mean) are considered clinically elevated.
Time frame: Baseline (week 0), 4 week assessment, 8 week assessment
Domain assessed: Opioid Use How assessed: Single item asking participants to indicate whether or not they currently using any opioid mediations.
Unit of measure is the number and rate of participants who indicated that they are currently using at least one opioid medication.
University of Washington
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05005416
Back Pain, Chronic Low-back Pain
San Diego, California, United States
View Trial DetailsNCT05301491
Back Pain, Chronic Low-back Pain
Gaziantep, Turkey (Türkiye)
View Trial DetailsNCT07190807
Back Pain, Chronic Leg Pain
Greenwood, Colorado, United States
View Trial DetailsNCT06931158
Chronic Low-back Pain, Chronic Pain
Providence, Rhode Island, United States
View Trial Details