Relieving Surgical Pain and Nausea With Light Therapy (LITENS)

Nuran Ayşen Pamir Aksoy

Status: Completed

Conditions: Pain, Postoperative; Nausea and Vomiting, Postoperative

Treatments: Device: blue colored lens glasses; Device: green colored lens glasses; Device: colorless (transparent) lens glasses

Study type: Interventional

Funder types: Other

Identifiers

NCT06772519

2024-18-687

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 4 patient groups, including a placebo group

Study Group-Blue lens glasses

Experimental group

Description:

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

Treatment:

Device: blue colored lens glasses

Study Group-Green lens glasses

Experimental group

Description:

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

Treatment:

Device: green colored lens glasses

Study Group-colorless (transparent) lens glasses

Placebo Comparator group

Description:

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

Treatment:

Device: colorless (transparent) lens glasses

Control group

No Intervention group

Description:

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