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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • Gülden Küçükakça Çelik

    Nevşehir, 50300

Other trials in Turkey (Türkiye)

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.

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 groups in NCT05134207
Study groupRoleWhat they receive
oral carbohydrate solutionExperimentalOral 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
controlNo interventionFrom 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.

  1. 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

  2. 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

  3. 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)
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. physiological parameter

    pulse rate/minute

    Measured: preoperative night at 10 pm

  7. physiological parameter

    pulse rate/minute

    Measured: immediately before going to the operation

  8. physiological parameter

    pulse rate/minute

    Measured: postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour.

  9. physiological parameter

    respiratory rate/minute

    Measured: preoperative night at 10 pm

  10. physiological parameter

    respiratory rate/minute

    Measured: immediately before going to the operation

  11. physiological parameter

    respiratory rate/minute

    Measured: postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour

  12. physiological parameter

    blood pressure (systolic and diastolic mmHg)

    Measured: preoperative night at 10 pm

  13. physiological parameter

    blood pressure (systolic and diastolic mmHg)

    Measured: immediately before going to the operation

  14. physiological parameter

    blood pressure (systolic and diastolic mmHg)

    Measured: postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour

  15. physiological parameter

    oxygen saturation (SpO2, %)

    Measured: preoperative night at 10 pm

  16. physiological parameter

    oxygen saturation (SpO2, %)

    Measured: immediately before going to the operation

  17. physiological parameter

    oxygen saturation (SpO2, %)

    Measured: postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour

  18. physiological parameter

    heat (Centigrade degree)

    Measured: preoperative night at 10 pm

  19. physiological parameter

    heat (Centigrade degree)

    Measured: immediately before going to the operation

  20. physiological parameter

    heat (Centigrade degree)

    Measured: postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour

  21. physiological parameter

    blood glucose (mg/dL)

    Measured: preoperative night at 10 pm

  22. physiological parameter

    blood glucose (mg/dL)

    Measured: immediately before going to the operation

  23. 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.

  1. First posted24 Nov 2021
  2. Study start11 Sep 2019
  3. Primary completion27 Aug 2021
  4. Study completion27 Aug 2021

Resources

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)
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 29241512
  • Ferguson 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 30496081
  • Shin 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 30985714
  • OECD, "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 21999144
  • Celiksular 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 27366573
  • Jovanovski-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 27442397
  • Juni 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 23500310
  • Haga 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 24322176
  • Gül 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 28343637
  • Dolgun 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

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.

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