Clinical Trials Logo

Clinical Trial Summary

Introduction: As after almost every surgical procedure, changes in the patient's system functions, acute pain and an increase in anxiety level occur after laparoscopic cholecystectomy. Uncontrolled pain and anxiety slows down the healing process, increases the possibility of opioid use and the risk of undesirable side effects, and increases mortality, and prolongs hospital discharge. Objective: The aim of the thesis study is to evaluate the effect of machine-based and manual hand massage applied in the postoperative period on pain, anxiety and gastrointestinal system functions in patients who have undergone laparoscopic cholecystectomy. Method: In the study planned as a randomized controlled experimental study; There will be 3 groups, 57 patients in each group, including the experimental groups and the control group, who have undergone laparoscopic cholecystectomy and hospitalized in the General Surgery Clinic of Bartın State Hospital, where machine-based and manual hand massage will be applied. In addition to the analgesic treatment requested by the physician at the 0th, 4th and 8th hours after the surgery, the experimental groups will be given 10 minutes of hand massage to each hand, and only the requested treatment will be applied to the control group. After the applications, the changes in the pain and anxiety levels of the patients as well as the effects on the gastrointestinal system functions will be recorded. 'Data Collection Form', 'Numerical Rating Scale', 'State-Trait Anxiety Scale' and 'Gastrointestinal functions monitoring form' will be used to collect the data and the data will be analyzed in SPSS 22.0 program.


Clinical Trial Description

As with almost every surgical procedure, changes in the patient's system functions, acute pain and an increase in anxiety level occur after laparoscopic cholecystectomy. Uncontrolled pain and anxiety slows down the healing process, increases the possibility of opioid use and the risk of undesirable side effects, and increases mortality, and prolongs hospital discharge. Massage; increases patient comfort, relaxation and satisfaction and reduces stress. Receptors associated with nerve fibers that transmit pain to the brain are mostly found in the feet and hands. For this reason, the effect of hand massage was wanted to be examined. The aim of the thesis study is to evaluate the effect of manual and machine-based application of hand massage on pain, anxiety and GIS functions after laparoscopic cholecystectomy. In the study planned as a randomized controlled experimental study; There will be 3 groups, 57 patients in each group, including the experimental groups and the control group, who have undergone laparoscopic cholecystectomy and hospitalized in the General Surgery Clinic of Bartın State Hospital, where machine-based and manual hand massage will be applied. First, the researcher will receive certified training on hand massage. Necessary permissions will be obtained to carry out the research. Patients who have undergone laparoscopic cholecystectomy in the general surgery service of Bartın state hospital and meet the inclusion criteria will be divided into 3 groups, 2 experimental and 1 control group, by block randomization. Before starting the application, the purpose of the research will be explained by the researcher and the informed consent of the individuals will be obtained. Data will be collected between September 2022 and June 2023. The patient will fill in the 'Section 1 of the Data Collection Form' and the 'Trait Anxiety Scale' at least 1 hour before the surgery in the preoperative period. The second part will be filled at the most appropriate time after the surgery. When the patient comes to the service after the surgery, before the first hour is up, that is, at the 0th hour and at the 4th and 8th hours, a hand massage device will be used and manual hand massage will be applied in addition to the treatment according to the clinical analgesia protocol, and hand massage will be applied for 10 minutes for each hand. The control group will be treated only according to the clinical analgesia protocol. Before the massage and after the massage at 0, 4 and 8 hours; On the other hand, the 'Numerical Rating Scale', State Anxiety Scale' will be applied to the control group during the periods when other groups are massaged without hand massage, and the 'Gastrointestinal Functions Monitoring Form' will be filled. All these evaluation stages will be done in the form of dividing 171 patients into 3 groups and evaluating them sequentially by numbering. Application of manual hand massage: The researcher will receive certified training on hand massage. Hand massage application method will be determined after the training. Application of machine-based hand massage: The pressure of the machine will be adjusted according to the manual massage application method. In manual massage and machine massage, machine adjustments will be made to keep the temperature and pressure difference as low as possible. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05636475
Study type Interventional
Source Bartin University
Contact
Status Active, not recruiting
Phase N/A
Start date October 1, 2022
Completion date September 2023

See also
  Status Clinical Trial Phase
Completed NCT03670849 - Image Fusion in the OR N/A
Withdrawn NCT04561583 - Effectiveness and Safety of LED Light Source System for Endoscope N/A
Completed NCT00872287 - Pain in Single Incision Laparoscopic Surgery Cholecystectomy Phase 4
Recruiting NCT06017167 - Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy Phase 2
Completed NCT05536557 - Bilateral External Oblique İntercostal (EOI) Plane Block in Patients Undergoing Laparoscopic Cholecystectomy. N/A
Recruiting NCT05794503 - Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex Early Phase 1
Completed NCT05998317 - Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy Phase 2/Phase 3
Completed NCT04759079 - The Effects of Acupuncture Against Postoperative Nausea and Vomit After Laparoscopic Cholecystectomy N/A
Recruiting NCT04138472 - Comparison Of Dexmedetomidine, Fentanyl And Lignocaine In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy N/A
Recruiting NCT06022926 - Investigation of the Intraoperative and Postoperative Effects of Warming Patients in Laparoscopic Cholecystectomy N/A
Completed NCT03067038 - Single Incision Versus Three Port Laparoscopic Cholecystectomy N/A
Completed NCT02469831 - Respiratory Mechanics and Metabolic Changes During Low Pressure Laparoscopic Cholecystectomy Phase 2
Completed NCT00886210 - Clinical Impact of Routine Abdominal Drainage After Laparoscopic Cholecystectomy N/A
Completed NCT00292214 - Comparing Intravenous and Oral Paracetamol for Cholecystectomy Phase 4
Recruiting NCT05533567 - Electroencephalographic Profiles During General Anesthesia: a Comparative Study of Remimazolam and Propofol N/A
Recruiting NCT05533580 - Differential Effects of Remimazolam and Propofol on Dynamic Cerebral Autoregulation During General Anesthesia N/A
Recruiting NCT05094193 - Trocar-site Infiltration Versus TAP-block N/A
Completed NCT03323684 - Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-cholecystectomy Analgesia N/A
Recruiting NCT04162106 - Feasibility of the Ultravision™ System in Low Pressure Laparoscopic Cholecystectomy Compared to Airseal® IFS N/A
Unknown status NCT01041183 - The Effect of Oral and Intravenous Ramosetron During Laparoscopic Cholecystectomy N/A