Fasting Clinical Trial
Official title:
The Effect of Oral Carbohydrate Solution Given Before Hip Artroplasty on Preoperative Anxiety and Postoperative Patient Comfort
NCT number | NCT05134207 |
Other study ID # | |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 11, 2019 |
Est. completion date | August 27, 2021 |
Verified date | March 2022 |
Source | Nevsehir Haci Bektas Veli University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Surgical interventions are not only a physiological trauma, but also a psychological and social trauma because they cause deterioration of the individual's comfort. Comfort is among the most basic human needs and provides a better care output. One of the conditions that cause deterioration of comfort and anxiety in patients is hunger and thirst before surgery. Since 1994, several guides published by professional groups in many countries on pre-operative fasting periods have published that clear liquids can be taken up to 2 hours before the surgery in elective surgeries, and solid foods can be taken up to 6 hours before the surgery. One of the basic principles of ERAS protocols, which include evidence-based care interventions applied at all stages of the surgical process, for the preoperative period is to ensure that the patient takes a carbohydrate drink up to two hours before anesthesia and to shorten the long fasting period. In many countries, the problems experienced by patients as a result of long-term hunger have been identified. When the comfort status of the patients who were given carbohydrate-rich drinks before the surgery was examined, it was observed that the symptoms such as thirst, hunger, insufficiency, fatigue, nausea, pain, anxiety and depression were reduced and oral carbohydrate solutions were recommended. In the literature, it is stated that the prolongation of the fasting period causes an increase in the anxiety of the person and negatively affects his comfort, and it is recommended to drink 800 ml of carbohydrate liquid food until midnight the day before the surgery and 400 ml of liquid carbohydrate food 2-3 hours before the surgery in order to provide metabolic satiety. The nurse, who is one of the health workers responsible for the care of the patient, has to manage the restriction of oral food and liquid intake and the comfort of the patient in the best way before the operation. Accordingly, in our study, the answers were sought whether the oral carbohydrate solution given before hip arthroplasty had an effect on anxiety and patient comfort.
Status | Completed |
Enrollment | 50 |
Est. completion date | August 27, 2021 |
Est. primary completion date | August 27, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Who volunteered to participate in the research, - Total hip replacement surgery planned, - Who are over 18 years old, - ASA I and II group, - First time hip replacement surgery Exclusion Criteria: - Diabetes mellitus, - In the emergency patient group, - with gastroesophageal reflux, - Those with esophageal disease (Hiatus hernia, esophagitis, achalasia…) - Having endocrine problem, - Diagnosed with ileus, - With pyloric stenosis, - ASA III and IV group, - Intravenous fluid administered before surgery, - Using drugs that affect blood glucose levels, - Previous hip replacement surgery - Body mass index over 35kg/m2 (The value obtained by dividing the weight in kilograms by the square of the height in meters), - Having a psychiatric and neurological diagnosis, poor general condition, - Needing all kinds of fluid and blood support in the pre-operative period, - Patients who use alcohol or cigarettes |
Country | Name | City | State |
---|---|---|---|
Turkey | Gülden Küçükakça Çelik | Nevsehir |
Lead Sponsor | Collaborator |
---|---|
Nevsehir Haci Bektas Veli University |
Turkey,
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* Note: There are 36 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | preoperative anxiety | State-Trait Anxiety Scale (The lowest score to be taken from the scale is 20, and the highest score is 80. High scores indicate high anxiety levels, low scores indicate low anxiety levels. | 10:00 pm the night before surgery | |
Primary | preoperative anxiety | State-Trait Anxiety Scale (The lowest score to be taken from the scale is 20, and the State-Trait Anxiety Scale (The lowest score to be taken from the scale is 20, and the highest score is 80. High scores indicate high anxiety levels, low scores indicate low | just before the patient is sent for surgery | |
Primary | patient comfort | Post Hip Replacement Comfort Scale (The highest average score obtained from the scale is 5 and the lowest average score is 1. A high score indicates high comfort, and a low mean score indicates low comfort.) | Considering that the discharge days of the patients would be different, it was applied on the second day after the operation. | |
Secondary | postoperative anxiety | Visual analog scale (Values range from 0 to 10 points, and higher values indicate increased severity of assessed symptoms.) | Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively. | |
Secondary | postoperative pain | Visual analog scale (Values range from 0 to 10 points, and higher values indicate increased severity of assessed symptoms.) | Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively | |
Secondary | postoperative sensation of thirst | Visual analog scale (Values range from 0 to 10 points, and higher values indicate increased severity of assessed symptoms.) | Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively | |
Secondary | postoperative nausea- vomiting | Visual analog scale (Values range from 0 to 10 points, and higher values indicate increased severity of assessed symptoms.) | Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively | |
Secondary | postoperative sensation of hunger | Visual analog scale (Values range from 0 to 10 points, and higher values indicate increased severity of assessed symptoms.) | Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively | |
Secondary | physiological parameter | pulse rate/minute | preoperative night at 10 pm | |
Secondary | physiological parameter | pulse rate/minute | immediately before going to the operation | |
Secondary | physiological parameter | pulse rate/minute | postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour. | |
Secondary | physiological parameter | respiratory rate/minute | preoperative night at 10 pm | |
Secondary | physiological parameter | respiratory rate/minute | immediately before going to the operation | |
Secondary | physiological parameter | respiratory rate/minute | postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour | |
Secondary | physiological parameter | blood pressure (systolic and diastolic mmHg) | preoperative night at 10 pm | |
Secondary | physiological parameter | blood pressure (systolic and diastolic mmHg) | immediately before going to the operation | |
Secondary | physiological parameter | blood pressure (systolic and diastolic mmHg) | postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour | |
Secondary | physiological parameter | oxygen saturation (SpO2, %) | preoperative night at 10 pm | |
Secondary | physiological parameter | oxygen saturation (SpO2, %) | immediately before going to the operation | |
Secondary | physiological parameter | oxygen saturation (SpO2, %) | postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour | |
Secondary | physiological parameter | heat (Centigrade degree) | preoperative night at 10 pm | |
Secondary | physiological parameter | heat (Centigrade degree) | immediately before going to the operation | |
Secondary | physiological parameter | heat (Centigrade degree) | postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour | |
Secondary | physiological parameter | blood glucose (mg/dL) | preoperative night at 10 pm | |
Secondary | physiological parameter | blood glucose (mg/dL) | immediately before going to the operation | |
Secondary | physiological parameter | blood glucose (mg/dL) | postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour |
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