Effect of Green Light Exposure at Different Times on the... | NCT07033949

Studies
Effect of Green Light Exposure at Different Times on the Pain of Subjects

NCT07033949

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

Status

Not yet recruiting

Last Update Posted

Jun 27, 2025Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Pain

Interventions

Green light glasses
Transparent light exposure

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2025Estimated

Primary Completion Date

Oct 19, 2025Estimated

Completion Date

Oct 19, 2025Estimated

First Submitted Date

Jun 15, 2025

First Submission Date that Met QC Criteria

Jun 15, 2025

First Posted Date

Jun 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2025

Last Update Posted Date

Jun 27, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Random numbers were generated by the computer to randomly assign patients who met the inclusion and exclusion criteria to the experimental group (exposed to green light) and the control group (exposed to transparent light). The patients were randomly assigned to three time periods (8:00-9:00, 12:00-13:00, 16:00-17:00) to receive a colored exposure with glasses: Therefore, in order to minimize bias and expectations, it was not informed to the patients which color would affect the pain during the arterial puncture. The patients rested in the pre-anesthesia room for 5 minutes, their heart rate (HR) was measured, and a pain sensitivity test (tender point) was conducted. Then, the patients wore the trial glasses and stayed in the pre-anesthesia room for 30 minutes, and they underwent arterial and venous punctures. While monitoring the patients' heart rate, the catheterization of the arterial and venous punctures was performed. Then, during the arterial and venous puncture, their pain scores (NRS) were recorded separately.

exposed to green light (green group) for 30 minutes. The above operation will be repeated to measure the patient's pain threshold.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Green light glasses	Device	Exposure to green light for 30 minutes	Green light exposure group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Pain sensitivity	assessed by pressure pain stimulation (magnitude of pressure, kilogram per square centimeter)	from the time before to 30 min after light exposure
Analgesic consumption during surgery

Other Outcomes

Measure	Description	Time Frame
Heart rate	assessed by the monitor using beat per minute	from before arterial puncture to 5min after the arterial puncture

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
guangyou ph.D Duan	Contact	18323376014		duangy@hospital.cqmu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Affiliated Hospital of Chongqing Medical University		Chongqing	Chongqing Municipality	4000000	China

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D059787	Acute Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided