Relieving Surgical Pain and Nausea With Light Therapy

NCT ID: NCT06772519

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-14
• Study Completion Date: 2025-12-30

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

Detailed Description

Since the hospital's architecture and clinical operation where the data will be collected have features that prevent patients from different groups from meeting, the single blind feature can be preserved. The pain assessment of the patients will be made with the numerical pain scale, and the nausea assessment will be made with the numerical nausea rating scale. In addition, data will be collected with the Patient Information Form prepared by the researchers in line with the literature.

Conditions

Pain, Postoperative; Nausea and Vomiting, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Study Group-Blue lens glasses

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

Group Type: EXPERIMENTAL

blue colored lens glasses

Intervention Type: 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-Green lens glasses

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

Group Type: EXPERIMENTAL

green colored lens glasses

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

colorless (transparent) lens glasses

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

green colored lens glasses

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.

Intervention Type: DEVICE

blue colored lens glasses

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.

Intervention Type: DEVICE

colorless (transparent) lens glasses

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.

Intervention Type: DEVICE

Other Intervention Names

green lens glasses; blue lens glasses; colored lens glasses

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

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

Sponsors

Nuran Ayşen Pamir Aksoy

OTHER

Sponsor Role: lead

Responsible Party

Nuran Ayşen Pamir Aksoy

Assist. Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Acibadem Atakent Hospital

Istanbul, Atakent, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2024-18-687

Identifier Type: -

Identifier Source: org_study_id