NCT07033949

Brief Summary

Patients who met the criteria and needed to undergo elective surgery via arterial and venous puncture were included in this center. They were randomly divided into three time periods (8:00-9:00, 12:00-13:00, 16:00-17:00) and were exposed to green light (experimental group) and transparent light (control group) respectively. The effects of green light exposure on acute perioperative pain in patients were observed at different times.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2025

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

June 15, 2025

Last Update Submit

June 24, 2025

Conditions

Keywords

Acute PainGreen light

Outcome Measures

Primary Outcomes (1)

  • Pain intensity during arteriovenous puncture

    assessed using number rating scale (0 to 10, which higher scores mean a worse pain intensity)

    The pain score during arterial puncture which about 2-3min

Secondary Outcomes (4)

  • 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

  • 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 5min after the arterial puncture

Study Arms (2)

Green light exposure group

EXPERIMENTAL

Before performing the arterial puncture, expose to green light for 30 minutes.

Device: Green light glasses

Transparent light exposure

PLACEBO COMPARATOR

Before performing the arterial puncture, expose to Transparent light for 30 minutes.

Device: Transparent light exposure

Interventions

Exposure to green light for 30 minutes

Green light exposure group

Exposure to transparent light for 30 minutes

Transparent light exposure

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age range: 18 - 50 years old.
  • ASA classification: I - III.
  • Planned to undergo abdominal surgeries requiring general anesthesia and arterial puncture (this is not necessary for the healthy volunteer group).
  • Obtained informed consent from the patients.

You may not qualify if:

  • Skin ulceration, allergic reactions, or dermatitis at the tested area.
  • Long-term use of analgesics or psychiatric medications.
  • History of color blindness or uncorrected cataracts.
  • Severe cardiovascular or respiratory diseases, inflammatory disorders, etc.
  • Failure of the first arterial puncture.
  • Communication difficulties, etc.

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

Central Study Contacts

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

October 19, 2025

Study Completion

October 19, 2025

Last Updated

June 27, 2025

Record last verified: 2025-06

Locations