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Not yet recruiting NCT07033949

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

No phase Interventional Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Green light glasses, Transparent light exposure.
Who it may be relevant to
Registry conditions: Pain. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Randomized Controlled Study on the Effect of Green Light Exposure at Different Times on the Pain of Subjects

Overview

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.

Interventions

  • Device Green light glasses
    Exposure to green light for 30 minutes
  • Device Transparent light exposure
    Exposure to transparent light for 30 minutes

Primary outcome measures

  • Pain intensity during arteriovenous puncture [Time frame: The pain score during arterial puncture which about 2-3min]
Secondary outcome measures (4)
  • Pain sensitivity [Time frame: from the time before to 30 min after light exposure]
  • Analgesic consumption during surgery [Time frame: From surgery beginning to the ending of the surgery]
  • Pain intensity after surgery [Time frame: From ending of the surgery to 24 hours after surgery]
  • Analgesic consumption after surgery [Time frame: From ending of the surgery to 24 hours after surgery]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

China · 1 center
  • The Second Affiliated Hospital of Chongqing Medical University — Chongqing

Identifiers

NCT: NCT07033949 · GLE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗