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N/A Completed N=100 Randomized Treatment

Digital Clinical Hypnosis for Chronic Pain Management

Source: ClinicalTrials.gov NCT06050083 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcomePrimary: Frequency of Using Rose Application — 81; 79; 64; 134 # of hypnosis sessions listened to

Summary

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Frequency of Using Rose Application
81; 79; 64; 134; 220; 274
PRIMARY
Continued Interest in Using Rose Application
2.5; 2.8
PRIMARY
Willingness to Pay for Continued Use of Rose Application
11
PRIMARY
Participant Satisfaction
2.8; 3.4
PRIMARY
System Usability Scale (SUS)
80.33; 87.31
SECONDARY
Average Pain - Past Week
5.81; 5.71; 5.92; 5.83; 5.69; 5.42
SECONDARY
Worst Pain - Past Week
7.23; 7.63; 7.35; 7.29; 7.19; 6.92
SECONDARY
PROMIS Sleep Disturbance Short Form 8a
57.3; 58.5; 55.2; 57.2; 58.4; 57.3
SECONDARY
PROMIS Pain Interference Short Form
64.3; 64.4; 60.5; 61.0; 64.4; 64.9
SECONDARY
PROMIS Anxiety Short Form 7a
58.0; 55.5; 57.8; 54.0; 60.4; 59.2
SECONDARY
Number of Participants Using Opioids
10; 2; 1; 2

Eligibility Criteria

Inclusion Criteria (self-report online and telephone screening by study staff):

  • 18 years old or older
  • Chronic Pain or Chronic Low Back Pain (i.e., pain in the low back that has been an ongoing problem for 3 months or more for at least half the days, as disclosed during self-report screening. The pain can be a primary condition or secondary to another health condition.
  • Average pain intensity in the past week ≥ 4 on a 0-10 scale
  • Reads, speaks, and understands English as noted in the medical record or disclosed during self-report screening
  • Has regular access to the internet
  • Has access to devices (phone, desktop, or other) with features (browsers, audio capabilities, etc.) that are congruent with the requirements of the digital therapeutic, as assessed by staff members during self-report screening.

Exclusion Criteria

  • History of (within past 5 years) or current diagnosis of primary psychotic or major thought disorder with active symptoms as noted in the medical record or disclosed during self-report screening
  • Psychiatric hospitalization within the past 6 months as noted in the medical record or disclosed during self-report screening
  • Psychiatric or behavioral conditions in which symptoms were unstable or severe within the past 6 months as noted in the medical record or disclosed during self-report screening;
  • Any psychiatric or behavioral issues as noted in the medical record or disclosed/observed during self-report screening that would indicate subject may be inappropriate for study;
  • Presenting symptoms at the time of screening that would interfere with participation, specifically active suicidal ideation with intent to harm oneself or others or active delusional or psychotic thinking;
  • Active malignancy (e.g., cancer not in remission) as noted in the medical record or disclosed during self-report screening;
  • Pain condition for which surgery is recommended and/or planned in the next six months as disclosed during self-report screening;
  • Currently receiving or have received hypnosis treatment for any pain condition as disclosed during self-report screening
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06050083). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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