- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06772519
Relieving Surgical Pain and Nausea With Light Therapy (LITENS)
Is It Possible to Reduce Surgical Pain and Nausea With Light Therapy? A Randomized Controlled, Non-Pharmacological Approach
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
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Atakent
-
Istanbul, Atakent, Turkey (Türkiye), 34752
- Acibadem Atakent Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study Group-Blue lens glasses
Patients who assigned to this group will wear blue-lens glasses postoperatively (min 8 h in a day)
|
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.
Other Names:
|
|
Experimental: Study Group-Green lens glasses
Patients who assigned to this group will wear green-lens glasses postoperatively (min 8 h in a day)
|
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.
Other Names:
|
|
Placebo Comparator: 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)
|
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.
|
|
No Intervention: Control group
Patients in this group will not be wearing any glasses.
Patients will be asked to participate for postoperative pain and nausea assesment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-operative pain
Time Frame: every 2 h during the post operative day1, and every 4 h during postoperative day 2.
|
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
Time Frame: every 2 h during the post operative day1, and every 4 h during postoperative day 2.
|
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.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Signs and Symptoms, Digestive
- Vomiting
- Nausea
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Postoperative Nausea and Vomiting
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Neurotransmitter Agents
- Membrane Transport Modulators
- Adrenergic Agents
- Central Nervous System Stimulants
- Dopamine Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Dopamine Agents
- Adrenergic Uptake Inhibitors
- Sympathomimetics
- Methamphetamine
Other Study ID Numbers
- 2024-18-687
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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