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NCT05625360 · ClinicalTrials.gov registry record · Phase 3
REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss
A Phase 3 study of Anxiety and Sleep Disturbance, sponsored by Wake Forest University Health Sciences.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 160
- Enrollment target
- 2
- Study locations
NCT05625360: Recruiting Phase 3 study of Anxiety and Sleep Disturbance, sponsored by Wake Forest University Health Sciences.
NCT05625360 is a Phase 3 study of Anxiety and Sleep Disturbance that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 160 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (64% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05625360, a Phase 3 study of Anxiety and Sleep Disturbance, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 160 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this research study is to learn how two different supportive programs may help women feel better after surgery. This study will measure if one type of supportive program is more useful than the other for improving wellbeing after surgery.
Primary Outcome
Efficacy of the intervention will be evaluated by measuring pain intensity scores between the two groups from the Patient Reported Outcomes Measurement Information System (PROMIS) pain intensity item (How would you rate your pain on average?), which is validated for assessing pain on a numeric rating scale from 0 (no pain) to 10 (worst imaginable pain). Models will be adjusted for the three randomization stratification variables (study site, type of cancer, type of surgery). Linear contrasts wil
Conditions Studied
Interventions
- OTHER eHealth Mindful Movement and Breathing
- OTHER Life Impacts Reflection
- OTHER PROMIS Questionnaires
Study Locations (2)
North Carolina
- Atrium Health - Levine Cancer Institute - Charlotte
- Wake Forest Baptist Comprehensive Cancer Center - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2023-06-13 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 3 |
What NCT05625360 shows while recruiting
NCT05625360 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (64% lower).
The record links to 5 conditions, with Anxiety appearing as the primary indexed condition, and to 3 interventions - of which eHealth Mindful Movement and Breathing is the first listed.
NCT05625360 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05625360 about?
NCT05625360 is a clinical study titled "REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss". The purpose of this research study is to learn how two different supportive programs may help women feel better after surgery. This study will measure if one type of supportive program is more useful than the other for improving wellbeing after surgery.
What is the current status of trial NCT05625360?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2023-06-13. Estimated completion is 2026-08-31.
What conditions does trial NCT05625360 study?
This clinical trial studies the following conditions: Anxiety, Sleep Disturbance, Malignant Female Reproductive System Neoplasm, Postoperative Pain, Acute, Postoperative Depression.
What interventions are being tested in trial NCT05625360?
The interventions under investigation include: eHealth Mindful Movement and Breathing (OTHER), Life Impacts Reflection (OTHER), PROMIS Questionnaires (OTHER).
Who is sponsoring clinical trial NCT05625360?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05625360 being conducted?
This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Anxiety
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05625360's enrollment target sits among peer trials
160 105th of 364 higher than 257 of 364 other Anxiety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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