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

NCT ID: NCT07033949

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2025-10-19

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Green light exposure group

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

Group Type: EXPERIMENTAL

Green light glasses

Intervention Type: DEVICE

Exposure to green light for 30 minutes

Transparent light exposure

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

Group Type: PLACEBO_COMPARATOR

Transparent light exposure

Intervention Type: DEVICE

Exposure to transparent light for 30 minutes

Interventions

Green light glasses

Exposure to green light for 30 minutes

Intervention Type: DEVICE

Transparent light exposure

Exposure to transparent light for 30 minutes

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age range: 18 - 50 years old.

2. ASA classification: I - III.

3. Planned to undergo abdominal surgeries requiring general anesthesia and arterial puncture (this is not necessary for the healthy volunteer group).

4. Obtained informed consent from the patients.

Exclusion Criteria

1. Skin ulceration, allergic reactions, or dermatitis at the tested area.

2. Long-term use of analgesics or psychiatric medications.

3. History of color blindness or uncorrected cataracts.

4. Severe cardiovascular or respiratory diseases, inflammatory disorders, etc.

5. Failure of the first arterial puncture.

6. Communication difficulties, etc.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Countries

China

Central Contacts

guangyou ph.D Duan

Role: CONTACT

duangy@hospital.cqmu.edu.cn

18323376014

Other Identifiers

GLE

Identifier Type: -

Identifier Source: org_study_id