Relieving Surgical Pain and Nausea With Light Therapy

NCT06772519 | Completed

• 1 other identifier: 2024-18-687
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the effectiveness of colored (green and blue lens) glasses as a non-pharmacological method in relieving post-surgical pain and postoperative nausea in kidney donors. The main hypothesis it aims to test: H1: Postoperative use of green-lensed glasses by patients who are kidney donors is effective in relieving surgical pain and postoperative nausea. H2: Postoperative use of blue-lensed glasses by patients who are kidney donors is effective in relieving surgical pain and postoperative nausea. Researchers will compare the blue-lens glasses and green-lens glasses groups to the transparent (colorless) glasses group and the non-glasses group to see if the colored lenses have an effect on postoperative pain and nausea. Participants in the intervention groups will be asked

• to wear the glasses (according to their randomly assigned group (blue/green/colorless/), immediately after they admitted to the ward postoperatively, at least 8 hours in a day, until their discharge
• to respond the pain and nausea assessment (every 2 hours during postop day 1 and every 4 hours during postop day 2) until their discharge Participants in the control group will be asked \- to respond the pain and nausea assessment (every 2 hours during postop day 1 and every 4 hours during postop day 2) until their discharge

Conditions

Pain, Postoperative; Nausea and Vomiting, Postoperative

Keywords

colored-lens glasses; postoperative pain; organ donor; kidney transplantation; postoperative nausea; blue light; green light

Outcome Measures

Primary Outcomes (2)

• Post-operative pain

  Post-operative pain level according to the numerical pain assessment scale

  every 2 h during the post operative day1, and every 4 h during postoperative day 2.

• Post-operative nausea

  Postoperative nausea level according to the numerical nausea rating scale

  every 2 h during the post operative day1, and every 4 h during postoperative day 2.

Study Arms (4)

Study Group-Blue lens glasses

EXPERIMENTAL

Patients who assigned to this group will wear blue-lens glasses postoperatively (min 8 h in a day)

Device: blue colored lens glasses

Study Group-Green lens glasses

EXPERIMENTAL

Patients who assigned to this group will wear green-lens glasses postoperatively (min 8 h in a day)

Device: green colored lens glasses

Study Group-colorless (transparent) lens glasses

PLACEBO COMPARATOR

Patients who assigned to this group will wear colerless (transparanet)-lens glasses postoperatively (min 8 h in a day)

Device: colorless (transparent) lens glasses

Control group

NO INTERVENTION

Patients in this group will not be wearing any glasses. Patients will be asked to participate for postoperative pain and nausea assesment.

Interventions

green colored lens glasses DEVICE

Researchers will compare the blue-lens glasses and green-lens glasses groups to the transparent (colorless) glasses group and the non-glasses group to see if the colored lenses have an effect on postoperative pain and nausea.

Also known as: green lens glasses

Study Group-Green lens glasses

blue colored lens glasses DEVICE

Researchers will compare the blue-lens glasses and green-lens glasses groups to the transparent (colorless) glasses group and the non-glasses group to see if the colored lenses have an effect on postoperative pain and nausea.

Also known as: blue lens glasses, colored lens glasses

Study Group-Blue lens glasses

colorless (transparent) lens glasses DEVICE

Researchers will compare the blue-lens glasses and green-lens glasses groups to the transparent (colorless) glasses group and the non-glasses group to see if the colored lenses have an effect on postoperative pain and nausea.

Study Group-colorless (transparent) lens glasses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being a donor for kidney transplantation
• Not having an obstacle to wearing glasses
• Being able to communicate verbally

You may not qualify if:

• Being color blind • Developing post-operative complications during the study period

Sponsors & Collaborators

• Nuran Ayşen Pamir Aksoy: lead

Study Sites (1)

Acibadem Atakent Hospital

Istanbul, Atakent, 34752, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 13, 2025
• Study Start: January 14, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

TU (1)