Clinical trial NCT05134207: The Effect of Oral Carbohydrate Solution on Anxiety and Comfort in Patients Undergoing Hip Arthroplasty
Official title: The Effect of Oral Carbohydrate Solution Given Before Hip Artroplasty on Preoperative Anxiety and Postoperative Patient Comfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Arthropathy
Fasting
Patient Comfort
Keywords: oral carbohydrate solution
anxiety
comfort
Lead sponsor: Nevsehir Haci Bektas Veli University
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Hip arthroplasty (HA) is a very common treatment method in orthopedic surgery worldwide. HA is considered a successful, safe and cost-effective medical intervention to regain pain-free mobility and functionality of the hip joint in patients with severe joint disease or trauma.

It is stated that the annual number of patients undergoing HA in the United States is 193,000, and this number is approximately one million worldwide. In the next 15 years, it is estimated that the number of patients undergoing HA will continue to increase in the world and in Turkey.

It is stated that health care services should start in the preoperative period and continue in the postoperative period, especially in HA surgeries performed due to limitation of mobility. Because HA application is seen as a major surgical intervention and as with many surgical interventions, it can affect the individual as a whole.

Surgical intervention is a combination of anesthesia, drug therapy, tissue trauma, blood loss and body temperature changes. These developing events stimulate metabolic changes and cause postoperative anxiety and stress response at the same time. Exposure of the human body to surgery or other trauma elicits a neurohumoral response and activates a catabolic process. Surgical stress causes an increase in the release of regulatory hormones such as catecholamine, glucagon and cortisol in the body and a decrease in insulin sensitivity. The increase in cortisol level leads to the development of insulin resistance and hyperglycemia, which have an important effect on the healing process. Changes in this process increase the risk of postoperative complications and mortality.

On the other hand, fasting the patient overnight as a standard practice in the preoperative period in order to reduce the risk of lung aspiration in elective surgery patients may cause a change in the insulin glucagon ratio. This increases the stress response to surgical trauma and may have a major impact on glycemic control and insulin resistance. Prolongation of the preoperative fasting period may cause negative effects such as feeling of hunger, anxiety, restlessness, headache, dehydration, hypovolemia and hypoglycemia. However, the increase in the preoperative fasting period causes a decrease in patient satisfaction, and causes undesirable conditions such as nausea and vomiting in the postoperative period, delaying the healing process and prolonging the hospital stay of the patients.

In the guidelines published in countries such as America, Canada and Europe, it is reported that the longer the fasting period, the negative effects on patient safety and comfort. In elective surgeries, it is recommended that clear liquids can be consumed up to the last two hours and solid foods up to six hours before the surgical procedure in order to reduce anxiety, reduce the negative effects of the stress response on the patient, and ensure patient comfort. In the guideline published by the Turkish Society of Anesthesiology and Reanimation (TARD) in 2005, it is recommended to comply with these criteria in patients who will undergo elective surgery. Therefore, modern perioperative care aims at maximizing the shortening of the fasting period before an elective surgery.

According to Enhanced Recovery After Surgery (ERAS) protocols, one of the elements of modern perioperative care is the administration of preoperative oral carbohydrate loading (OCS). In the literature; oral carbohydrate solution administration before elective surgery; It is stated that it is absorbed from the stomach of the patient in an average of 90 minutes, reduces protein catabolism in the muscles, increases glycogen storage in the liver and reduces insulin resistance. In addition, in other studies conducted in abdominal, orthopedic and cardiac surgery; It has been determined that OCS reduces postoperative metabolic stress, preserves lean body mass and muscle strength, and increases patient comfort by reducing the length of hospital stay.

The concept of patient comfort is defined as the comfort that facilitates daily life. In providing the health care needs, which are extremely stressful for the patient, nurses apply nursing interventions for comfort, which is a concept unique to the individual, allowing the patient to experience less anxiety, be more peaceful and overcome their problems.

Discomforts experienced by the patient during the operation or procedures (pain, nausea, vomiting, hypothermia, anxiety, etc.) may increase the patient's anxiety and may be the main reason for the decrease in comfort. The nurse should provide all necessary nursing interventions to reduce or eliminate the situations that will cause anxiety in the patient before and after each procedure to be applied to the patient. With all these practices, patients can receive a quality nursing care, contribute to their faster recovery and increase their quality of life.

Quality patient care in surgical nursing; should be shaped within the framework of ethical principles such as not harming and providing benefit. In the literature; Evidence for the duration of fasting in the preoperative period is reflected in clinical practice, emphasizing the need to prevent patients from being harmed without putting them at risk. Thus, by managing the hunger period within the scope of evidence-based practices; It is stated that many therapeutic benefits can be obtained, such as reducing anxiety, discomfort, headache, thirst and hunger in the preoperative period, and providing patient comfort by reducing nausea, vomiting and dehydration in the postoperative period.

Managing food and fluid restriction in line with the guidelines in the preoperative period is one of the important responsibilities of the surgical nurse. Thus, the comfort of the patients will be increased, their anxiety will be reduced, and they will be able to return to their normal lives as soon as possible. Working from here; It was aimed to determine the effect of preoperative OCS on anxiety and patient comfort in patients undergoing HA.

Eligibility criteria: 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

Primary outcomes:
measure: preoperative anxiety
timeFrame: 10:00 pm the night before surgery
measure: preoperative anxiety
timeFrame: just before the patient is sent for surgery
measure: patient comfort
timeFrame: Considering that the discharge days of the patients would be different, it was applied on the second day after the operation.
Secondary outcomes:
measure: postoperative anxiety
timeFrame: Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively.
measure: postoperative pain
timeFrame: Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively
measure: postoperative sensation of thirst
timeFrame: Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively
measure: postoperative nausea- vomiting
timeFrame: Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively
measure: postoperative sensation of hunger
timeFrame: Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively
measure: physiological parameter
timeFrame: preoperative night at 10 pm
measure: physiological parameter
timeFrame: immediately before going to the operation
measure: physiological parameter
timeFrame: postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour.
measure: physiological parameter
timeFrame: preoperative night at 10 pm
measure: physiological parameter
timeFrame: immediately before going to the operation
measure: physiological parameter
timeFrame: postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour
measure: physiological parameter
timeFrame: preoperative night at 10 pm
measure: physiological parameter
timeFrame: immediately before going to the operation
measure: physiological parameter
timeFrame: postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour
measure: physiological parameter
timeFrame: preoperative night at 10 pm
measure: physiological parameter
timeFrame: immediately before going to the operation
measure: physiological parameter
timeFrame: postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour
measure: physiological parameter
timeFrame: preoperative night at 10 pm
measure: physiological parameter
timeFrame: immediately before going to the operation
measure: physiological parameter
timeFrame: postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour
measure: physiological parameter
timeFrame: preoperative night at 10 pm
measure: physiological parameter
timeFrame: immediately before going to the operation
measure: physiological parameter
timeFrame: postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour
Other outcomes:
Locations:
city: Nevşehir
country: Turkey
facility: Gülden Küçükakça Çelik
Study officials:
affiliation: Nevşehir Hacı Bektaş Veli University
name: Gülden Küçükakça Çelik, Phd
role: PRINCIPAL_INVESTIGATOR
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