A Randomized Controlled Study on the Effect of Green Light Exposure at Different Times on the Pain of Subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Pain intensity during arterial puncture
Study Overview
Brief Summary
This study investigated the effects of green-light exposure on pain sensitivity in healthy volunteers and on perioperative pain in surgical patients. Healthy volunteers underwent 30-min green-light exposure at three different times of day (08:00-09:00, 12:00-13:00, and 16:00-17:00) on separate days using a within-subject design, with a washout period of at least 2 days between sessions. Surgical patients undergoing elective surgery under general anesthesia with preoperative arterial puncture were randomly assigned in a 1:1 ratio to either a green-light intervention group or a sham-device control group. The assigned intervention was initiated before arterial puncture and continued throughout surgery. The effects of green-light exposure on pain sensitivity, procedural pain, and perioperative pain were evaluated.
Detailed Description
The study consisted of two components. In the healthy-volunteer component, participants underwent a 30-min green-light exposure at three different times of day (08:00-09:00, 12:00-13:00, and 16:00-17:00) on separate days in a within-subject design, with a washout period of at least 2 days between sessions. Pain threshold, pain tolerance, and cold pain sensitivity were assessed before and after each exposure.
In the surgical component, eligible patients were randomly assigned in a 1:1 ratio to either the green-light intervention group or the sham-device control group using a computer-generated random sequence. Participants wore identical wearable GLED glasses for 30 min before arterial puncture and throughout surgery. In the intervention group, the device delivered 511-515 nm green light at 100 lux; in the control group, the device remained powered off and participants were exposed only to ambient room light. Care providers, investigators not involved in intervention administration, and clinical outcome assessors were blinded to group allocation. Personnel responsible for device allocation and administration were unblinded and were not involved in perioperative clinical care or outcome assessment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy volunteers:
- •Age 18-65 years.
- •ASA physical status I.
- •1. Age 18-65 years.
- •ASA physical status I-III.
- •Scheduled for elective abdominal surgery under general anesthesia requiring arterial puncture.
Exclusion Criteria
- •Skin ulceration, dermatitis, or allergic reactions at the study site.
- •Chronic use of analgesics or psychiatric medications.
- •Color blindness or uncorrected cataracts.
- •Severe cardiovascular, respiratory, or inflammatory diseases.
- •Failure of the initial arterial puncture attempt (surgical cohort only).
- •Inability to communicate or provide informed consent.
Arms & Interventions
Sham-device control group
Participants wore identical GLED light-therapy glasses for 30 min before arterial puncture and throughout surgery. The device remained powered off, and participants were exposed only to ambient room light.
Intervention: Sham GLED glasses (Device)
Green light exposure group
Participants wore GLED light-therapy glasses delivering 511-515 nm green light at 100 lux for 30 min before arterial puncture and throughout surgery.
Intervention: Green light glasses (Device)
Outcomes
Primary Outcomes
Pain intensity during arterial puncture
Time Frame: The pain score during arterial puncture
Numeric Rating Scale (NRS), ranging from 0 to 10, with higher scores indicating greater pain intensity.
Pain intensity during arteriovenous puncture
Time Frame: The pain score during arterial puncture which about 2-3min
assessed using number rating scale (0 to 10, which higher scores mean a worse pain intensity)
Secondary Outcomes
- Pain sensitivity(Immediately before and 30 minutes after light exposure)
- Pain intensity after surgery(From ending of the surgery to 24 hours after surgery)
- Pain sensitivity(from the time before to 30 min after light exposure)
- Analgesic consumption during surgery(From surgery beginning to the ending of the surgery)
- Analgesic consumption after surgery(From ending of the surgery to 24 hours after surgery)