Quality of Life Clinical Trial
Official title:
Effectiveness of Thread Embedding Acupuncture Analgesia at the EX-B2 Point at the First Lumbar Level Combined With Standard Therapy on Acute Pain and Quality of Life After Post Laparoscopic Living Donor Nephrectomy
Verified date | January 2024 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Kidney transplantation is the main option besides hemodialysis and continuous ambulatory peritoneal dialysis (CAPD) to prolong and improve the quality of life for patients with end-stage renal disease. The main option for obtaining organs from living donors is surgical action to remove the kidney (nephrectomy) using the laparoscopic method (laparoscopic live donor nephrectomy or LLDN). Postoperative management of LDNH in the form of intravenous paracetamol 1000 mg cannot overcome innovative pain and has drug-related risk effects. Non-pharmacological pain management is the first line of pain management. One non-pharmacological therapy that can be an option is acupuncture. Thread embedding acupuncture (TEA) is an acupuncture method that uses certain medical threads such as catgut or polydioxanone (PDO) which are inserted into subcutaneous tissue or muscle at certain acupuncture points. The working mechanism of TEA in treating pain is through local mechanisms in the form of releasing adenosine which binds to adenosine A1 receptors, releasing substance P, inhibiting the expression and activation of Nuclear Factor Kappa B; through a segmental mechanism in the form of a control gate mechanism; through extrasegmental mechanisms in the form of downward pain inhibition pathways; through a central mechanism in the form of release of endogenous opioids in the hypothalamus. ATB can provide a continuous stimulating effect of infiltration and acceleration of tissue regeneration, increasing anti-pain.
Status | Completed |
Enrollment | 6 |
Est. completion date | January 3, 2024 |
Est. primary completion date | December 22, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. Subjects are prospective kidney donors who will undergo laparoscopic living donor nephrectomy (LLDN). 2. Adult patients with an age range of 21-60 years. 3. Willing to take part in this research and sign informed consent. Exclusion Criteria: 1. The patient has a history of hypersensitive reactions to thread embedding acupuncture (TEA). 2. The patient has a history of keloids or is prone to keloid formation. 3. The patient has skin disease at the location of the TEA installation area in the back area. 4. There are abnormalities in the neurological examination of the lower extremities. 5. Have a history of spinal surgery or are scheduled to undergo spinal surgery within 7 months after the LLDN procedure. 6. There is scoliosis based on clinical examination. 7. There are other specific diagnoses that can cause secondary low back pain such as inflammatory spondylitis, spinal infection, or tumor. 8. Female patients who plan to become pregnant within 7 months after the LLDN procedure. 9. The patient has a body mass index (BMI) below 18 kg/m2 10. The patient has uncontrolled diabetes mellitus. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Faculty of Medicine Universitas Indonesia | Jakarta Pusat | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain severity with Visual Analog Scale | Visual Analog Scale (VAS) that score 0 is no pain to 100 the worse pain A higher result means worse outcomes and lower result means better outcomes | 7 days before laparoscopic living donor nephrectomy and on 1st, 2nd, 14th day after laparoscopic living donor nephrectomy procedure | |
Secondary | Quality of Life with Short Form 36 | Quality of life using Short Form 36 scoring system. It contains 8 domains such as physical function, role limitation due to physical health, role limitation due to emotional health, energy/fatigue, emotional well-being, social functioning, pain, general health. The scoring s calculated with online calculator provided by MDApp website. The result is in percentage, with higher result means better quality of life. | 7 days before laparoscopic living donor nephrectomy, and on 1st, 2nd, and 14th day after laparoscopic living donor nephrectomy procedure |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
Completed |
NCT06238557 -
Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
|
||
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT05472935 -
Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers
|
N/A | |
Recruiting |
NCT04444544 -
Quality of Life and High-Risk Abdominal Cancer Surgery
|
||
Completed |
NCT04281953 -
Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
|
||
Recruiting |
NCT05546931 -
Mobile Health Program for Rural Hypertension
|
N/A | |
Active, not recruiting |
NCT04746664 -
Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia
|
N/A | |
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Recruiting |
NCT04142827 -
The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)
|
N/A | |
Active, not recruiting |
NCT05903638 -
A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility
|
N/A | |
Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
Completed |
NCT03813420 -
Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level
|
N/A | |
Recruiting |
NCT05550545 -
Infant RSV Infections and Health-related Quality of Life of Families
|
||
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Recruiting |
NCT05233020 -
Robotic Versus Hybrid Assisted Ventral Hernia Repair
|
N/A | |
Terminated |
NCT03304184 -
The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life
|
Phase 3 | |
Completed |
NCT05063305 -
Probiotics, Immunity, Stress, and QofL
|
N/A | |
Recruiting |
NCT05380856 -
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
|
N/A |