Green Light Therapy to Reduce Pain and Promote Wellness After Surgery: A Randomized Controlled Trial in Adult Post-Operative Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incisional Pain Intensity with Movement
研究概览
简要总结
This is an unblinded, parallel group randomized controlled trial to evaluate bright green light as an adjunct therapy after surgery at UPMC Shadyside. The primary outcome measure will be pain intensity with secondary outcome measures including opioid requirements, sleep quality, mood, and overall post-operative recovery. Specific aims/hypotheses for this study are as follows:
Aim 1: To assess bright green light therapy's potential as a complementary post-operative analgesic strategy in patients recovering from surgery Hypothesis 1: Participants exposed to bright green light, in comparison to dim white (ambient) light, will have improved postoperative pain scores and lower opioid use.
Aim 2: To examine the impact of bright green light therapy on patient-centered measures of post-operative recovery that may be related to improved circadian function.
Hypothesis 2: Participants exposed to bright green light, in comparison to dim white (ambient) light, will have improved quality of post-operative recovery, enhanced sleep, and reduced anxiety and depression.
详细描述
This research study is being done to evaluate the use of light therapy following surgery at UPMC Shadyside Hospital (Pittsburgh, PA). Light therapy after surgery may reduce pain and pain medication requirements, and it may improve sleep, mood, and overall post-surgery recovery. The proposed study design of a randomized controlled trial investigates the use of bright green light therapy for post-operative pain management and wellness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >/= 18 years
- •Planned to undergo laparoscopic or robotic surgery at UPMC Shadyside Hospital
- •Anticipated post-operative length of stay >/= 48 hours
- •Able to speak and read English fluently, with the capacity to provide informed consent and complete the associated surveys independently
排除标准
- •Pregnancy
- •History of significant ocular issues/dysfunction (†‡ ) (e.g., glaucoma, ocular trauma, macular degeneration, cataracts) that would interfere with the ocular mechanism of action
- •History of significant neurological disease (‡) (e.g., traumatic brain injury, stroke, neurodegenerative disease) that would compromise the reliability of pain screening and/or interfere with the central mechanism of action
- •History of bipolar disorder or schizophrenia, which could increase the risk of an adverse reaction to light exposure (i.e., acute mania)
- •History of splenectomy, which would interfere with the mechanism of action
- •Ocular issues corrected with contact lenses or spectacle corrective eyeglasses will NOT be considered a criterion for exclusion ‡Unclear cases will be at the discretion of the PI
研究组 & 干预措施
Bright Green Light Exposure Arm
Subjects randomized to this group will be exposed to bright green light via the Day Light Classic Plus light therapy lamp fitted with an appropriate color filter. The light will be administered for 4 hours daily for up to three days post-operatively while the subject is in the hospital.
干预措施: Bright Green Light Therapy (Device)
Dim White Light Exposure Arm
Subjects randomized to this group will be exposed to dim white light via the Day Light Classic Plus light therapy lamp fitted with an appropriate color filter. The light will be administered for 4 hours daily for up to three days post-operatively while the subject is in the hospital.
干预措施: Dim White Light Therapy (Device)
结局指标
主要结局
Incisional Pain Intensity with Movement
时间窗: Post-Operative Day 2
Incisional pain with movement (after coughing) will be reported using a Numerical Rating Scale (NRS), scored from 0 to10, with 0 indicates "no pain" and 10 indicates "the worst pain imaginable". Post-intervention NRS on Post-Operative Day 2 will be compared between study arms as the primary outcome.
次要结局
- Incisional Pain Intensity at Rest(Post-Operative Day 2)
- Oral Morphine Equivalents (OME)(Post-Operative Day 1, and Post-Operative Day 2)
- Sleep Disturbance(Post-Operative Day 7)
- Depression(Post-Operative Day 7)
- Anxiety(Post-Operative Day 7)
- Overall quality of Post-Operative Recovery(on Post-Operative Day 2, and Post-Operative Day 7)
- Hospital Length of Stay(Up to 30 Days Post-Operatively)
研究者
Rebecca E Kotcher, MD
Principal Investigator
University of Pittsburgh