NCT07033949

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2026

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2026

Completed
Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

9 months

First QC Date

June 15, 2025

Last Update Submit

September 15, 2026

Conditions

Keywords

Acute PainGreen light

Outcome Measures

Primary Outcomes (1)

  • Pain intensity during arterial puncture

    Numeric Rating Scale (NRS), ranging from 0 to 10, with higher scores indicating greater pain intensity.

    The pain score during arterial puncture

Secondary Outcomes (4)

  • Pain sensitivity

    Immediately before and 30 minutes after light exposure

  • Analgesic consumption during surgery

    From surgery beginning to the ending of the surgery

  • Pain intensity after surgery

    From ending of the surgery to 24 hours after surgery

  • Analgesic consumption after surgery

    From ending of the surgery to 24 hours after surgery

Other Outcomes (1)

  • Heart rate

    from before arterial puncture to 5 minutes after the arterial puncture

Study Arms (2)

Green light exposure group

EXPERIMENTAL

Participants wore GLED light-therapy glasses delivering 511-515 nm green light at 100 lux for 30 min before arterial puncture and throughout surgery.

Device: Green light glasses

Sham-device control group

SHAM COMPARATOR

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.

Device: Sham GLED glasses

Interventions

Exposure to green light for 30 minutes and during the surgery.

Green light exposure group

Identical GLED glasses remained powered off for 30 min before arterial puncture and throughout surgery.

Sham-device control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers:
  • Age 18-65 years.
  • ASA physical status I.
  • \. Age 18-65 years. 2. ASA physical status I-III. 3. Scheduled for elective abdominal surgery under general anesthesia requiring arterial puncture.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 4000000, China

Location

MeSH Terms

Conditions

PainAcute Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Guangyou Duan

    The Second Affiliated Hospital, Chongqing Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2025

First Posted

June 24, 2025

Study Start

July 1, 2025

Primary Completion

April 4, 2026

Study Completion

April 6, 2026

Last Updated

September 17, 2026

Record last verified: 2026-09

Locations