Clinique Bizet
Paris, 75016, France
Location status: Recruiting
Location contact
Bouchra BENKESSOU, PM
CONTACT
Georges ABI LAHOUD, Principal Investigator
CONTACT
goerges ABI LAHOUD, Pr
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07062146
This study involves patients undergoing lumbar spine surgery (lumbar arthrodesis). It compares the effects of Reiki, an energy-based therapy, with conventional approaches to relieve postoperative pain.
The goal is to determine whether this non-drug method can help reduce pain, limit the use of painkillers, and enhance patient comfort during recovery.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Paris, 75016, France
Location status: Recruiting
Bouchra BENKESSOU, PM
CONTACT
Georges ABI LAHOUD, Principal Investigator
CONTACT
goerges ABI LAHOUD, Pr
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Reiki sessions for 30 minutes, on Day-7 before the surgery and on D15 after the surgery
Sham sessions for 30 minutes, on D-7 before the surgery and on D15 after the surgery,
Time frame: DAY 15
The Visual Analog Scale is a subjective measurement tool commonly used to assess the intensity of pain. It consists of a horizontal 10-centimeter line on which the patient marks a point that reflects their experience.
Minimum and maximum values:
0 = complete absence of the symptom
10 = the most severe imaginable intensity of the symptom
Score interpretation:
Higher scores indicate greater symptom intensity
Lower scores indicate lesser intensity
Time frame: DAY 30
The SF-12 (Short-Form Health Survey) a validated questionnaire designed to assess health-related quality of life across physical and mental domains. It is a shortened version of the SF-36, containing 12 items that cover eight key health dimensions.
Scoring:
Time frame: from Day 1 to Day 30
This daily diary was designed by the research team to record pain intensity using the Visual Analog Scale (VAS), from the day of discharge up to 30 days post-intervention.
The Visual Analog Scale is a subjective measurement tool commonly used to assess the intensity of pain. It consists of a horizontal 10-centimeter line on which the patient marks a point that reflects their experience.
0 = complete absence of the symptom 10 = the most severe imaginable intensity of the symptom
Higher scores indicate greater symptom intensity Lower scores indicate lesser intensity
Time frame: at Day 30
the Clinical Global Impression (CGI) is a clinician-rated scale used to assess the global change in a patient's condition following a medical or therapeutic intervention, compared to their state at baseline.
Evaluated on a 7-point scale :
Time frame: at Day 15 and Day 30
The International Visual Wound Color Scale (IVWCS) This scale is a visual assessment tool that helps clinicians evaluate wound healing by identifying and interpreting the dominant colors present in the wound bed.
Each color corresponds to a specific tissue type or healing stage.
Color Categories and Their Meanings:
Requires cleaning and possibly debridement May indicate microbial presence or inflammation
Requires urgent medical attention Typically treated with debridement and moist dressings
Time frame: from day 1 to day 30
This daily diary was designed by the research team and records the daily consumption of analgesics from the day of discharge to 30 days post-intervention.
Classification of Analgesics in the Daily Diary Analgesic consumption will be categorized according to the standard analgesic step classification:
Contact information is provided by the study sponsor or research team.
Bouchra BENKESSOU, PM
CONTACT
georges ABI LAHOUD, Professeur
CONTACT
Clinique Bizet
Other
Evaluation of the Effect of Reiki on Pain After Spinal Fusion: A Comparative, Randomized, Pilot Study
Acronym: REDAL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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