The Effect of Foot Massage Applied Before and After Cholecystectomy Surgery on Anxiety, Pain and Comfort Level
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Perianesthesia Comfort Scale
研究概览
简要总结
Aim and objectives:The aim of this study is to examine the effect of foot massage on reducing pain and anxiety and increasing the comfort level in patients undergoing laparoscopic cholecystectomy.
Design:The study is a randomized controlled experimental study with a pretest posttest control group.
Methods:This study will be carried out in Niğde Ömer Halisdemir University Training and Research Hospital General Surgery Clinic. Participants were divided into massage group and control group. Vital signs of the massage group will be taken 2 hours before the operation and Surgical Anxiety Scale will be applied to adult patients (n=40). At this stage, the patient's both feet will be massaged for a total of 20 minutes, 10 minutes each. Vital signs and anxiety status of the patients will be evaluated 30 minutes after the procedure. Postoperative vital signs, pain severity, anxiety and comfort level will be evaluated and after the evaluation, a foot massage will be applied to both feet of the patient for 10 minutes, for a total of 20 minutes. Vital signs and pain levels of the patients will be evaluated at the 5th, 30th, 60th, 90th and 120th minutes after the massage, and their comfort and anxiety levels will be evaluated at the 30th minute. The same data will be collected from patients in the control group (n=40) without foot massage. Data will be collected from Patient Descriptive Information Form, Vital Signs Follow-up Form, Surgical Anxiety Scale for Adult Patients, Perianesthesia Comfort Scale, Numerical Pain Scale.will be used.
详细描述
The study is a randomized controlled experimental study with pre-test post-test control group.The independent variable of the study is foot massage application, the dependent variables are preoperative anxiety level, postoperative pain severity, vital signs (blood pressure, pulse, number of breaths, body temperature, oxygen saturation), anxiety level and comfort level.The research will be conducted at the General Surgery Clinic of Niğde Ömer Halisdemir University Training and Research Hospital.Patients admitted to the General Surgery Clinic for Laparocopic Cholecystectomy surgery after being admitted to the service: The anamnesis form is filled out, the file containing the examinations is prepared,the hunger condition is questioned, the necessary preparations are made for the patient to go to the surgery and the transfer to the operating room is ensured. After the operation; vital signs are checked in postoperative care. The treatment protocol steps are applied in the clinic. Within these steps: I . Usually 2000cc mayi is prepared (LR, 5% Dextrose,0.9% NaCl) II. Antibiotics are administered according to the form specified at the doctor's request (Cefazol or Desefin 2 x 1 V.b.). III. Analgesics are applied according to the patient's condition and the patient's prescription (Oxamen, Tilcotil, Dolantin, Dichlorone, Voltaren, Novalgine) A power analysis was performed to determine the number of people to be included in the research. The strength of the test was calculated with the G*Power 3.1 program. Similar references have been made in the relevant literature. According to the mean and standard deviation values of the Perianesthesia Comfort Scale (PCS) and Numerical Pain Scale (NPS) of the study, the sample size was calculated as 14 people for PPE values and 76 people for PPE values. The study should reach 76 people, including 38 people for each group at the 95% power, 5% significance level and 0.768 effect size. Considering the decrease in the number of patients, it is aimed to recruit a total of 80 people, 40 for each group, to the study.
It was taken by randomization according to the order of arrival in order to avoid bias in the people who will be included in the study.Randomization table "https://www.random.org " it was created using the address. To Investigate the received subjects were matched with the randomization table according to the order of arrival and divided into groups impartially.
Criteria for Inclusion in the Research:
-
Who volunteered to participate in the study,
-
who is 18 years of age or older,
-
Without communication difficulties and mental disabilities related to vision, hearing and speech,
-
The hypertension problem has been brought under control,
-
Blood pressure measurement does not need to be performed on an outpatient basis,
-
Any complications after surgery (bleeding, nausea, vomiting, etc.) that did not occur,
-
Performing cholecystectomy surgery,
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Who volunteered to participate in the study,
- •those who are 18 years of age or older,
- •Without communication difficulties and mental disabilities related to vision, hearing and speech,
- •Hypertension problem has been controlled,
- •Blood pressure measurement does not need to be performed on an outpatient basis,
- •Any complications after surgery (bleeding, nausea, vomiting, etc.) that did not occur,
- •Application of cholecystectomy surgery,
- •Having a pain assessment score of 4 and above after surgical intervention,
- •For patients in the experimental group; infectious disease on the skin, local infection, open lesion/wound, scar tissue, edema,hematoma, thrombophlebitis, deep vein thrombosis, lymphangitis, coagulation disorder, varicose veins, osteoporosis, osteomyelitis, hepatitis, inflammatory and degenerative joint diseases, advanced neuropathy due to diabetes, on the toes deformity, November, who has not recently experienced fractures, dislocations, ruptures of muscle fibers, tendons or fascia,
- •Analgesic is not applied before the first attempt, which is planned to be applied after the operation,
- •Any medication, etc. without substance abuse,
- •* No chronic pain in any part of the body,
- •All patients who are not pregnant will be included in the sample.
排除标准
- •Any complications such as severe bleeding, nausea, vomiting develop after surgical intervention.,
- •Patient-controlled analgesia (HKA) is applied for pain control after surgical intervention
- •Patients who have at least one drain placed at the surgical site are excluded from the sample, as this may affect the level of pain he will be released.
- •Termination Criteria: The individual feels uncomfortable during the application or to leave the study if he wants, the work will be terminated.
结局指标
主要结局
Perianesthesia Comfort Scale
时间窗: Two days
PCS consisting of 24 items and before the individual's surgery, it is a 6-point Likert-type scale that questions their general thoughts and feelings about the process during and after. The scale scoring varies between 1 and 6 points Dec, the scale questions are scored as 1= "I Strongly Disagree" 6= "I Strongly Agree".The highest total score of PCS is 144 and the lowest total score is 24.
次要结局
- Numerical Pain Scale(Two days)
研究者
Nesibe Sultan ÇINAROĞLU
PhD Student
Saglik Bilimleri Universitesi