Weighted Blankets for Post-Surgical Pain

Overseen By Laura K Case, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Opioids

Disqualifiers: Pregnancy, Claustrophobia, Incarceration, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3 months

168 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

You are afraid of small, enclosed spaces.

You are currently in jail.

You regularly take a lot of strong painkillers.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Lighter blanket Experimental Treatment 1 Intervention

A lighter blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.

Group II: Heavier blanket Experimental Treatment 1 Intervention

A heavier blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.

Group III: Waitlist control Active Control 1 Intervention

No blanket will be provided until the end of the study; participants will sleep with their normal bedding.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does effective postoperative pain management influence surgical morbidity? Rosenberg, J., Kehlet, H.[2017]

In a study involving 60 patients undergoing abdominal surgeries, both neostigmine + buprenorphine and ketamine + buprenorphine provided effective postoperative pain relief, with significant reductions in pain scores over 22 hours.

There was no significant difference in pain relief, vital parameters, or side effects between the two treatment groups, indicating that both combinations are safe and effective options for preemptive epidural analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Choubey, S., Singh, RB.[2022]

In a study of 500 patients undergoing major abdominal surgery, the use of relaxation techniques and music significantly reduced postoperative pain compared to a control group, indicating these methods can be effective adjuncts to opioid medication.

The combination of relaxation and music provided the greatest pain relief, suggesting that these non-pharmacological interventions can enhance patient comfort during recovery, especially when opioid pain relief is insufficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relief of postoperative pain with jaw relaxation, music and their combination. Good, M., Stanton-Hicks, M., Grass, JA., et al.[2019]

Epidural analgesia is more effective than systemic analgesia in managing postoperative pain, leading to benefits like earlier ambulation and hospital discharge.

Spinal opioids and various neural blockade techniques, such as intercostal nerve block, can significantly reduce postoperative pain and narcotic use, improving recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of postoperative pain: review of current techniques and methods. Lutz, LJ., Lamer, TJ.[2019]

Continuous intravenous analgesia with morphine using elastomeric infusors provided effective pain relief for burn patients post-surgery, achieving a visual analog scale (VAS) score of less than 3 within 2 hours of starting treatment.

The method demonstrated a low incidence of side effects compared to traditional morphine delivery methods, with high patient satisfaction, suggesting it is a safe and efficient option for managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of postoperative pain for burn patients with intravenous analgesia in continuous perfusion using elastomeric infusors. García Barreiro, J., Rodriguez, A., Cal, M., et al.[2013]

Acute postoperative pain is often not managed effectively worldwide, highlighting a significant gap in patient care that can impact recovery and overall health.

The article discusses new analgesics and advanced delivery methods that could enhance pain management strategies for patients experiencing moderate-to-severe postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative pain management: new, convenient analgesic therapies. Power, I., McCormack, J.[2019]

Effective pain assessment and management in the recovery room is crucial for postoperative patients, as it significantly impacts their recovery experience and overall satisfaction.

Providing patients with information about their recovery process empowers them and can improve their pain management outcomes, highlighting the importance of communication in postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain management in recovery. McMain, L.[2018]

Citations

1. Belgium pubmed.ncbi.nlm.nih.gov

Pain relief and clinical outcome: from opioids to balanced analgesia. [2005]

2. England pubmed.ncbi.nlm.nih.gov

Effects of relaxation and music on postoperative pain: a review. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Does effective postoperative pain management influence surgical morbidity? [2017]

4. India pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

Relief of postoperative pain with jaw relaxation, music and their combination. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Management of postoperative pain: review of current techniques and methods. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment of postoperative pain for burn patients with intravenous analgesia in continuous perfusion using elastomeric infusors. [2013]

8. England pubmed.ncbi.nlm.nih.gov

Postoperative pain management: new, convenient analgesic therapies. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Pain management in recovery. [2018]