168 Participants Needed

Weighted Blankets for Post-Surgical Pain

LK
Overseen ByLaura K Case, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Diego
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using high-dose opioids, you may not be eligible to participate.

What data supports the effectiveness of the treatment Weighted Blanket for post-surgical pain?

While there is no direct research on weighted blankets for post-surgical pain, studies show that relaxation techniques, like music and jaw relaxation, can help reduce pain after surgery. These methods, similar to the calming effect of a weighted blanket, suggest that such treatments might also help manage post-surgical pain.12345

How does the treatment of using weighted blankets for post-surgical pain differ from other treatments?

Weighted blankets are unique because they provide a non-drug, physical form of comfort and pressure that may help reduce anxiety and pain perception, unlike traditional pain management methods that rely on medications or nerve blocks.36789

What is the purpose of this trial?

The strongest psychological predictor of persistent pain after surgery is anxiety before surgery. The weight of blanket a person uses overnight may alter both anxiety and pain levels. The proposed study will determine whether a heavier or lighter blanket alters presurgical anxiety or postsurgical pain in individuals undergoing a breast surgery. We will also study whether any blanket-induced changes in postsurgical pain are related to reductions in anxiety before surgery induced by the blanket. Finally, we will examine clinical and psychological factors that might explain differences in how surgical patients respond to blanket weight. This research will improve our understanding of whether blanket weight can alter anxiety before a surgery or pain after a surgery.

Eligibility Criteria

This trial is for English-speaking individuals scheduled for breast surgery, with a BMI of at least 18.5 and the strength to lift up to 15 pounds. They must be willing to sleep with a weighted blanket for up to three months and use their smartphone to submit data. Pregnant individuals, chronic high-dose opioid users, current/previous weighted blanket users, those with claustrophobia or who are incarcerated cannot participate.

Inclusion Criteria

I can use my smartphone and data plan for the study's app.
I am scheduled for breast surgery.
My BMI is over 18.5 and I can safely lift 15 pounds.
See 2 more

Exclusion Criteria

You are afraid of small, enclosed spaces.
You are currently in jail.
You regularly take a lot of strong painkillers.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use either a heavier or lighter blanket overnight for 3 months to assess changes in anxiety and postsurgical pain

3 months
Initial visit for blanket assignment, follow-up assessments at 1 week, 1 month, and 3 months

Follow-up

Participants are monitored for changes in anxiety and pain levels after the treatment period

1 month

Treatment Details

Interventions

  • Weighted Blanket
Trial Overview The study is testing if using heavier or lighter blankets before surgery can reduce anxiety and post-surgical pain in patients undergoing breast surgery. It will also explore how these potential changes in pain relate to pre-surgery anxiety levels and identify factors that influence patient responses.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Lighter blanketExperimental Treatment1 Intervention
A lighter blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.
Group II: Heavier blanketExperimental Treatment1 Intervention
A heavier blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.
Group III: Waitlist controlActive Control1 Intervention
No blanket will be provided until the end of the study; participants will sleep with their normal bedding.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+

Findings from Research

Adequate postoperative pain relief is crucial for improving surgical outcomes, particularly in lower body surgeries, but the effectiveness of opioids administered via patient-controlled analgesia (PCA) or epidural techniques has not shown significant benefits in outcomes.
The best pain relief is achieved through balanced analgesia techniques that combine epidural opioids with local anesthetics and systemic non-steroidal anti-inflammatory drugs, suggesting a multi-faceted approach to pain management is necessary.
Pain relief and clinical outcome: from opioids to balanced analgesia.Kehlet, H.[2005]
Relaxation techniques and music have been found to effectively reduce emotional and observed pain in postoperative patients, although they are less effective in decreasing sensory pain or the need for opioids.
The review highlights significant variability in study designs and methodologies, suggesting that more rigorous randomized controlled trials are needed to determine the most effective types of relaxation and music interventions for pain management in postoperative settings.
Effects of relaxation and music on postoperative pain: a review.Good, M.[2019]
Postoperative pain relief methods like nonsteroidal anti-inflammatory drugs and patient-controlled analgesia do not significantly improve surgical outcomes after major procedures, according to several controlled trials.
In lower body surgeries, using epidural or spinal anesthesia for pain relief can reduce blood loss and complications, suggesting that effective pain management may be more beneficial when part of a comprehensive rehabilitation program.
Does effective postoperative pain management influence surgical morbidity?Rosenberg, J., Kehlet, H.[2017]

References

Pain relief and clinical outcome: from opioids to balanced analgesia. [2005]
Effects of relaxation and music on postoperative pain: a review. [2019]
Does effective postoperative pain management influence surgical morbidity? [2017]
Preemptive Epidural Analgesia for Postoperative Pain Relief Revisited: Comparison of Combination of Buprenorphine and Neostigmine with Combination of Buprenorphine and Ketamine in Lower Abdominal Surgeries, A Double-blind Randomized Trial. [2022]
Relief of postoperative pain with jaw relaxation, music and their combination. [2019]
Management of postoperative pain: review of current techniques and methods. [2019]
Treatment of postoperative pain for burn patients with intravenous analgesia in continuous perfusion using elastomeric infusors. [2013]
Postoperative pain management: new, convenient analgesic therapies. [2019]
Pain management in recovery. [2018]
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