Clinical trial NCT06772519: Relieving Surgical Pain and Nausea with Light Therapy
Official title: Is It Possible to Reduce Surgical Pain and Nausea with Light Therapy? a Randomized Controlled, Non-Pharmacological Approach
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pain, Postoperative
Nausea and Vomiting, Postoperative
Keywords: colored-lens glasses
postoperative pain
organ donor
kidney transplantation
postoperative nausea
blue light
green light
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Post-operative pain
timeFrame: every 2 h during the post operative day1, and every 4 h during postoperative day 2.
measure: Post-operative nausea
timeFrame: every 2 h during the post operative day1, and every 4 h during postoperative day 2.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Atakent Hospital
state: Atakent
Study officials:
References: