Hip ArthropathyNCT05134207
The Effect of Oral Carbohydrate Solution on Anxiety and Comfort in Patients Undergoing Hip Arthroplasty
A study testing oral carbohydrate solution in people with Hip Arthropathy and Fasting, run by Nevsehir Haci Bektas Veli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hip Arthropathy, Fasting, Patient Comfort
- What is being tested?
- oral carbohydrate solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Sep 2019to 27 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diabetes mellitus,
- In the emergency patient group,
- with gastroesophageal reflux,
- Those with esophageal disease (Hiatus hernia, esophagitis, achalasia…)
- Having endocrine problem,
- Diagnosed with ileus,
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oral Carbohydrate Solution Given Before Hip Artroplasty on Preoperative Anxiety and Postoperative Patient Comfort
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.
Read the 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.
- Conditions
- Hip Arthropathy, Fasting, Patient Comfort
- Being tested
- oral carbohydrate solution
- Keywords
- oral carbohydrate solution, anxiety, comfort
- Medical subject headings
- Fasting, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral carbohydrate solutionDietary supplement
Patients in the intervention group; Preop oral carbohydrate solution was ingested orally twice within 10 minutes, as 800 ml at 24:00 the night before the surgery and 400 ml at 06:00 2 hours before the surgery.
| Study group | Role | What they receive |
|---|---|---|
| oral carbohydrate solution | Experimental | Oral carbohydrate solution was given orally to the experimental group as 800 ml at 24:00 the night before the surgery and 400 ml at 06:00 2 hours before the intervention. Receives: Dietary Supplement: oral carbohydrate solution |
| control | No intervention | From 24:00 on the night before the surgical intervention, food and water intake was prohibited for the patients in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10:00 pm the night before surgery
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
Measured: just before the patient is sent for surgery
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.)
Measured: Considering that the discharge days of the patients would be different, it was applied on the second day after the operation.
Secondary outcomes (23)
postoperative anxiety
Visual analog scale (Values range from 0 to 10 points, and higher values indicate increased severity of assessed symptoms.)
Measured: Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively.
postoperative pain
Visual analog scale (Values range from 0 to 10 points, and higher values indicate increased severity of assessed symptoms.)
Measured: Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively
postoperative sensation of thirst
Visual analog scale (Values range from 0 to 10 points, and higher values indicate increased severity of assessed symptoms.)
Measured: Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively
postoperative nausea- vomiting
Visual analog scale (Values range from 0 to 10 points, and higher values indicate increased severity of assessed symptoms.)
Measured: Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively
postoperative sensation of hunger
Visual analog scale (Values range from 0 to 10 points, and higher values indicate increased severity of assessed symptoms.)
Measured: Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively
physiological parameter
pulse rate/minute
Measured: preoperative night at 10 pm
physiological parameter
pulse rate/minute
Measured: immediately before going to the operation
physiological parameter
pulse rate/minute
Measured: postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour.
physiological parameter
respiratory rate/minute
Measured: preoperative night at 10 pm
physiological parameter
respiratory rate/minute
Measured: immediately before going to the operation
physiological parameter
respiratory rate/minute
Measured: postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour
physiological parameter
blood pressure (systolic and diastolic mmHg)
Measured: preoperative night at 10 pm
physiological parameter
blood pressure (systolic and diastolic mmHg)
Measured: immediately before going to the operation
physiological parameter
blood pressure (systolic and diastolic mmHg)
Measured: postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour
physiological parameter
oxygen saturation (SpO2, %)
Measured: preoperative night at 10 pm
physiological parameter
oxygen saturation (SpO2, %)
Measured: immediately before going to the operation
physiological parameter
oxygen saturation (SpO2, %)
Measured: postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour
physiological parameter
heat (Centigrade degree)
Measured: preoperative night at 10 pm
physiological parameter
heat (Centigrade degree)
Measured: immediately before going to the operation
physiological parameter
heat (Centigrade degree)
Measured: postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour
physiological parameter
blood glucose (mg/dL)
Measured: preoperative night at 10 pm
physiological parameter
blood glucose (mg/dL)
Measured: immediately before going to the operation
physiological parameter
blood glucose (mg/dL)
Measured: postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start11 Sep 2019
- Primary completion27 Aug 2021
- Study completion27 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Hip ArthropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nevsehir Haci Bektas Veli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülden Küçükakça Çelik, Nevsehir Haci Bektas Veli University
- Investigators
- Gülden Küçükakça Çelik, Phd, Principal investigator, Nevşehir Hacı Bektaş Veli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134207
- Status last verified
- Mar 2022
- First submitted
- 14 Oct 2021
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saray Kilic H, Tastan S. Development of post hip replacement comfort scale. Appl Nurs Res. 2017 Dec;38:169-174. doi: 10.1016/j.apnr.2017.10.004. Epub 2017 Oct 16.
PubMed 29241512Ferguson RJ, Palmer AJ, Taylor A, Porter ML, Malchau H, Glyn-Jones S. Hip replacement. Lancet. 2018 Nov 3;392(10158):1662-1671. doi: 10.1016/S0140-6736(18)31777-X.
PubMed 30496081Shin HR, Park K, Seo J, An SH, Yeom SR, Kwon YD. Acupuncture for perioperative care of total hip arthroplasty: A systemic review of controlled trials and meta-analysis. Medicine (Baltimore). 2019 Apr;98(15):e15198. doi: 10.1097/MD.0000000000015198.
PubMed 30985714OECD, "Hip and knee replacement", in Health at a Glance 2015: OECD Indicators, OECD Publishing, Paris, 2015. doi.org/10.1787/health_glance-2015-36-en
Yaban ZŞ, Karaöz S. "Total Kalça Protezi Ameliyatında Hemşirelik Bakımı", C.Ü.Hemşirelik Yüksekokulu Dergisi, 2007; 11 (1):47-53.
Widnyana IMG, Senapathi TGA, Aryabiantara IW. "Metabolic Stress Response Attenuate by Oral Glucose Preoperatively in Patient Underwent Major Surgery with General Anesthesia", Int J Anesth Pain Med. 2017; 3(1): 1-5.10.21767/2471-982X.100015
Wolf AR. Effects of regional analgesia on stress responses to pediatric surgery. Paediatr Anaesth. 2012 Jan;22(1):19-24. doi: 10.1111/j.1460-9592.2011.03714.x. Epub 2011 Oct 14.
PubMed 21999144Celiksular MC, Saracoglu A, Yentur E. The Influence of Oral Carbohydrate Solution Intake on Stress Response before Total Hip Replacement Surgery during Epidural and General Anaesthesia. Turk J Anaesthesiol Reanim. 2016 Jun;44(3):117-23. doi: 10.5152/TJAR.2016.65265. Epub 2016 Jun 1.
PubMed 27366573Jovanovski-Srceva M, Kuzmanovska B, Mojsova M, Kartalov A, Shosholcheva M, Temelkovska-Stevanoska M, Gavrilovska A, Stavridis S, Spirovski Z, Kondov B, Kokareva A, Todorov R, Spirovska T. Insulin Resistance, Glycemia and Cortisol Levels in Surgical Patients who Had Preoperative Caloric Load with Amino Acids. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2015;36(3):61-70. doi: 10.1515/prilozi-2015-0079.
PubMed 27442397Juni RP, Duckers HJ, Vanhoutte PM, Virmani R, Moens AL. Oxidative stress and pathological changes after coronary artery interventions. J Am Coll Cardiol. 2013 Apr 9;61(14):1471-81. doi: 10.1016/j.jacc.2012.11.068.
PubMed 23500310Haga Y, Wada Y, Takeuchi H, Furuya T. Evaluation of modified estimation of physiologic ability and surgical stress in patients undergoing surgery for choledochocystolithiasis. World J Surg. 2014 May;38(5):1177-83. doi: 10.1007/s00268-013-2383-0.
PubMed 24322176Gül A, Andsoy II, Üstündağ H, Özkaya BÖ, "Assessment of preoperative fasting time in elective general surgery", The Journal of Macro Trends in Health and Medicine, 2013; 1(1): 1-8.
Dolgun E, Yavuz M, Eroglu B, Islamoglu A. Investigation of Preoperative Fasting Times in Children. J Perianesth Nurs. 2017 Apr;32(2):121-124. doi: 10.1016/j.jopan.2014.12.005. Epub 2016 Jun 21.
PubMed 28343637Dolgun E, Taşdemir N, Ter N, Yavuz M. "Cerrahi hastalarının ameliyat öncesi aç kalma sürelerinin incelenmesi", FÜ Sağ. Bil. Tıp Dergisi. 2011; 25(1): 11-15.
Soreide E, Eriksson LI, Hirlekar G, Eriksson H, Henneberg SW, Sandin R, Raeder J; (Task Force on Scandinavian Pre-operative Fasting Guidelines, Clinical Practice Committee Scandinavian Society of Anaesthesiology and Intensive Care Medicine). Pre-operative fasting guidelines: an update. Acta Anaesthesiol Scand. 2005 Sep;49(8):1041-7. doi: 10.1111/j.1399-6576.2005.00781.x.
PubMed 16095440
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Carbohydrate Solution Given Before Hip Artroplasty on Preoperative Anxiety and Postoperative Patient Comfort
- ClinicalTrials.gov ID
- NCT05134207
- Conditions
- Hip Arthropathy, Fasting, Patient Comfort
- Keywords
- oral carbohydrate solution, anxiety, comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nevsehir Haci Bektas Veli UniversityUniversity, hospital or other
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 27 Aug 2021 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| oral carbohydrate solution | Experimental | Dietary Supplement: oral carbohydrate solutionOral carbohydrate solution was given orally to the experimental group as 800 ml at 24:00 the night before the surgery and 400 ml at 06:00 2 hours before the intervention. |
| control | No intervention | –From 24:00 on the night before the surgical intervention, food and water intake was prohibited for the patients in the control group. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- Diabetes mellitus,
- In the emergency patient group,
- with gastroesophageal reflux,
- Those with esophageal disease (Hiatus hernia, esophagitis, achalasia…)
- Having endocrine problem,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral carbohydrate solutionPatients in the intervention group; Preop oral carbohydrate solution was ingested orally twice within 10 minutes, as 800 ml at 24:00 the night before the surgery and 400 ml at 06:00 2 hours before the surgery. | Dietary supplement | oral carbohydrate solution |
Primary outcome
preoperative anxiety
Time frame: 10:00 pm the night before surgery
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.
preoperative anxiety
Time frame: just before the patient is sent for surgery
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
patient comfort
Time frame: Considering that the discharge days of the patients would be different, it was applied on the second day after the operation.
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.)
23 secondary outcomes
postoperative anxiety
Time frame: Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively.
postoperative pain
Time frame: Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively
postoperative sensation of thirst
Time frame: Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively
postoperative nausea- vomiting
Time frame: Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively
postoperative sensation of hunger
Time frame: Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively
physiological parameter
Time frame: preoperative night at 10 pm
physiological parameter
Time frame: immediately before going to the operation
physiological parameter
Time frame: postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour.
physiological parameter
Time frame: preoperative night at 10 pm
physiological parameter
Time frame: immediately before going to the operation
physiological parameter
Time frame: postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour
physiological parameter
Time frame: preoperative night at 10 pm
physiological parameter
Time frame: immediately before going to the operation
physiological parameter
Time frame: postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour
physiological parameter
Time frame: preoperative night at 10 pm
physiological parameter
Time frame: immediately before going to the operation
physiological parameter
Time frame: postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour
physiological parameter
Time frame: preoperative night at 10 pm
physiological parameter
Time frame: immediately before going to the operation
physiological parameter
Time frame: postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour
physiological parameter
Time frame: preoperative night at 10 pm
physiological parameter
Time frame: immediately before going to the operation
physiological parameter
Time frame: postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Results publication: PubMed 29241512Saray Kilic H, Tastan S. Development of post hip replacement comfort scale. Appl Nurs Res. 2017 Dec;38:169-174. doi: 10.1016/j.apnr.2017.10.004. Epub 2017 Oct 16.
- Results publication: PubMed 30496081Ferguson RJ, Palmer AJ, Taylor A, Porter ML, Malchau H, Glyn-Jones S. Hip replacement. Lancet. 2018 Nov 3;392(10158):1662-1671. doi: 10.1016/S0140-6736(18)31777-X.
- Results publication: PubMed 30985714Shin HR, Park K, Seo J, An SH, Yeom SR, Kwon YD. Acupuncture for perioperative care of total hip arthroplasty: A systemic review of controlled trials and meta-analysis. Medicine (Baltimore). 2019 Apr;98(15):e15198. doi: 10.1097/MD.0000000000015198.
- Results publicationOECD, "Hip and knee replacement", in Health at a Glance 2015: OECD Indicators, OECD Publishing, Paris, 2015. doi.org/10.1787/health_glance-2015-36-en
- Results publicationYaban ZŞ, Karaöz S. "Total Kalça Protezi Ameliyatında Hemşirelik Bakımı", C.Ü.Hemşirelik Yüksekokulu Dergisi, 2007; 11 (1):47-53.
- Results publicationWidnyana IMG, Senapathi TGA, Aryabiantara IW. "Metabolic Stress Response Attenuate by Oral Glucose Preoperatively in Patient Underwent Major Surgery with General Anesthesia", Int J Anesth Pain Med. 2017; 3(1): 1-5.10.21767/2471-982X.100015
- Results publication: PubMed 21999144Wolf AR. Effects of regional analgesia on stress responses to pediatric surgery. Paediatr Anaesth. 2012 Jan;22(1):19-24. doi: 10.1111/j.1460-9592.2011.03714.x. Epub 2011 Oct 14.
- Results publication: PubMed 27366573Celiksular MC, Saracoglu A, Yentur E. The Influence of Oral Carbohydrate Solution Intake on Stress Response before Total Hip Replacement Surgery during Epidural and General Anaesthesia. Turk J Anaesthesiol Reanim. 2016 Jun;44(3):117-23. doi: 10.5152/TJAR.2016.65265. Epub 2016 Jun 1.
- Results publication: PubMed 27442397Jovanovski-Srceva M, Kuzmanovska B, Mojsova M, Kartalov A, Shosholcheva M, Temelkovska-Stevanoska M, Gavrilovska A, Stavridis S, Spirovski Z, Kondov B, Kokareva A, Todorov R, Spirovska T. Insulin Resistance, Glycemia and Cortisol Levels in Surgical Patients who Had Preoperative Caloric Load with Amino Acids. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2015;36(3):61-70. doi: 10.1515/prilozi-2015-0079.
- Results publication: PubMed 23500310Juni RP, Duckers HJ, Vanhoutte PM, Virmani R, Moens AL. Oxidative stress and pathological changes after coronary artery interventions. J Am Coll Cardiol. 2013 Apr 9;61(14):1471-81. doi: 10.1016/j.jacc.2012.11.068.
- Results publication: PubMed 24322176Haga Y, Wada Y, Takeuchi H, Furuya T. Evaluation of modified estimation of physiologic ability and surgical stress in patients undergoing surgery for choledochocystolithiasis. World J Surg. 2014 May;38(5):1177-83. doi: 10.1007/s00268-013-2383-0.
- Results publicationGül A, Andsoy II, Üstündağ H, Özkaya BÖ, "Assessment of preoperative fasting time in elective general surgery", The Journal of Macro Trends in Health and Medicine, 2013; 1(1): 1-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülden Küçükakça Çelik, Phd principal investigator
Nevşehir Hacı Bektaş Veli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral carbohydrate solution in people with Hip Arthropathy and Fasting, run by Nevsehir Haci Bektas Veli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preoperative anxiety (time frame: 10:00 pm the night before surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05134207, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.