The Effect of Oral Carbohydrate Solution on Anxiety and Comfort in Patients Undergoing Hip Arthroplasty

NCT05134207 | Completed DMC

• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Arthropathy; Fasting; Patient Comfort

Keywords

oral carbohydrate solution; anxiety; comfort

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (23)

• postoperative anxiety

  Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively.

• postoperative pain

  Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively

• postoperative sensation of thirst

  Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively

• postoperative nausea- vomiting

  Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively

• postoperative sensation of hunger

  Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively

Study Arms (2)

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.

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.

Interventions

oral carbohydrate solution DIETARY_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.

oral carbohydrate solution

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nevsehir Haci Bektas Veli University: lead

Study Sites (1)

Gülden Küçükakça Çelik

Nevşehir, 50300, Turkey (Türkiye)

Location

Related Publications (37)

• 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.

  PMID: 29241512 RESULT

• 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.

  PMID: 30496081 RESULT

• 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.

  PMID: 30985714 RESULT

• 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

  RESULT

• Yaban ZŞ, Karaöz S. "Total Kalça Protezi Ameliyatında Hemşirelik Bakımı", C.Ü.Hemşirelik Yüksekokulu Dergisi, 2007; 11 (1):47-53.

  RESULT

• 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

  RESULT

• 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.

  PMID: 21999144 RESULT

• 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.

  PMID: 27366573 RESULT

• 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.

  PMID: 27442397 RESULT

• 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.

  PMID: 23500310 RESULT

• 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.

  PMID: 24322176 RESULT

• 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.

  RESULT

• 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.

  PMID: 28343637 RESULT

• 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.

  RESULT

• 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.

  PMID: 16095440 RESULT

• Love C. "Fasting the patient before operation", Journal of Orthopaedic Nursing. 2002;1(6): 41-48.

  RESULT

• Ludwig RB, Paludo J, Fernandes D, Scherer F. Lesser time of preoperative fasting and early postoperative feeding are safe? Arq Bras Cir Dig. 2013 Jan-Mar;26(1):54-8. doi: 10.1590/s0102-67202013000100012. English, Portuguese.

  PMID: 23702872 RESULT

• Brady M, Kinn S, Stuart P. Preoperative fasting for adults to prevent perioperative complications. Cochrane Database Syst Rev. 2003;(4):CD004423. doi: 10.1002/14651858.CD004423.

  PMID: 14584013 RESULT

• Pedziwiatr M, Pisarska M, Matlok M, Major P, Kisielewski M, Wierdak M, Natkaniec M, Budzynski P, Rubinkiewicz M, Budzynski R. Randomized Clinical Trial To Compare The Effects Of Preoperative Oral Carbohydrate Loading Versus Placebo On Insulin Resistance And Cortisol Level After Laparoscopic Cholecystectomy. Pol Przegl Chir. 2015 Aug;87(8):402-8. doi: 10.1515/pjs-2015-0079.

  PMID: 26495916 RESULT

• Nygren J, Thacker J, Carli F, Fearon KC, Norderval S, Lobo DN, Ljungqvist O, Soop M, Ramirez J; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective rectal/pelvic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):285-305. doi: 10.1007/s00268-012-1787-6. No abstract available.

  PMID: 23052796 RESULT

• Kisialeuski M, Pedziwiatr M, Matlok M, Major P, Migaczewski M, Kolodziej D, Zub-Pokrowiecka A, Pisarska M, Budzynski P, Budzynski A. Enhanced recovery after colorectal surgery in elderly patients. Wideochir Inne Tech Maloinwazyjne. 2015 Apr;10(1):30-6. doi: 10.5114/wiitm.2015.48697. Epub 2015 Jan 27.

  PMID: 25960790 RESULT

• Tamura T, Yatabe T, Kitagawa H, Yamashita K, Hanazaki K, Yokoyama M. Oral carbohydrate loading with 18% carbohydrate beverage alleviates insulin resistance. Asia Pac J Clin Nutr. 2013;22(1):48-53. doi: 10.6133/apjcn.2013.22.1.20.

  PMID: 23353610 RESULT

• Svanfeldt M, Thorell A, Hausel J, Soop M, Rooyackers O, Nygren J, Ljungqvist O. Randomized clinical trial of the effect of preoperative oral carbohydrate treatment on postoperative whole-body protein and glucose kinetics. Br J Surg. 2007 Nov;94(11):1342-50. doi: 10.1002/bjs.5919.

  PMID: 17902094 RESULT

• Wang ZG, Wang Q, Wang WJ, Qin HL. Randomized clinical trial to compare the effects of preoperative oral carbohydrate versus placebo on insulin resistance after colorectal surgery. Br J Surg. 2010 Mar;97(3):317-27. doi: 10.1002/bjs.6963.

  PMID: 20101593 RESULT

• Yuill KA, Richardson RA, Davidson HI, Garden OJ, Parks RW. The administration of an oral carbohydrate-containing fluid prior to major elective upper-gastrointestinal surgery preserves skeletal muscle mass postoperatively--a randomised clinical trial. Clin Nutr. 2005 Feb;24(1):32-7. doi: 10.1016/j.clnu.2004.06.009.

  PMID: 15681099 RESULT

• Amer MA, Smith MD, Herbison GP, Plank LD, McCall JL. Network meta-analysis of the effect of preoperative carbohydrate loading on recovery after elective surgery. Br J Surg. 2017 Feb;104(3):187-197. doi: 10.1002/bjs.10408. Epub 2016 Dec 21.

  PMID: 28000931 RESULT

• Smith MD, McCall J, Plank L, Herbison GP, Soop M, Nygren J. Preoperative carbohydrate treatment for enhancing recovery after elective surgery. Cochrane Database Syst Rev. 2014 Aug 14;2014(8):CD009161. doi: 10.1002/14651858.CD009161.pub2.

  PMID: 25121931 RESULT

• Hausel J, Nygren J, Lagerkranser M, Hellstrom PM, Hammarqvist F, Almstrom C, Lindh A, Thorell A, Ljungqvist O. A carbohydrate-rich drink reduces preoperative discomfort in elective surgery patients. Anesth Analg. 2001 Nov;93(5):1344-50. doi: 10.1097/00000539-200111000-00063.

  PMID: 11682427 RESULT

• Sada F, Krasniqi A, Hamza A, Gecaj-Gashi A, Bicaj B, Kavaja F. A randomized trial of preoperative oral carbohydrates in abdominal surgery. BMC Anesthesiol. 2014 Oct 17;14:93. doi: 10.1186/1471-2253-14-93. eCollection 2014.

  PMID: 25364300 RESULT

• Kolcaba K. "Comfort theory and practice: a vision for holistic health care and research", Springer Publishing Co, New York. 2003

  RESULT

• Wilson L, Kolcaba K. Practical application of comfort theory in the perianesthesia setting. J Perianesth Nurs. 2004 Jun;19(3):164-73; quiz 171-3. doi: 10.1016/j.jopan.2004.03.006.

  PMID: 15195275 RESULT

• Yılmaz E, Çeçen D, Toğaç HK, Mutlu S, Kara H, Aslan A. "Ameliyat Sürecindeki Hastaların Konfor Düzeyleri ve Hemşirelik Bakımları", Celal Bayar Üniversitesi Sağlık Bilimleri Enstitüsü Dergisi.2018; 5(1):3-9.

  RESULT

• Winslow EH, Crenshaw JT. Preoperative fasting. Am J Nurs. 2010 Dec;110(12):12; author reply 12. doi: 10.1097/01.NAJ.0000391216.02330.78. No abstract available.

  PMID: 21107043 RESULT

• Abd El-Naby AG, El-Sayed ZM. "Preoperative Fasting Time and Selected Postoperative Outcomes among Patients Undergoing Abdominal Surgeries: Correlation Study", Journal of Health, Medicine and Nursing. 2016; 26:109-119.

  RESULT

• Demirdağ H, Karaöz S. "Ameliyat öncesi besin/sıvı kısıtlamasına ilişkin hastaların deneyimleri ve hemşirelerin konu ile ilgili bilgi ve uygulamaları", Florence Nightingale Hemşirelik Dergisi. 2015; 23(1): 1-10.

  RESULT

• Imbelloni LE, Pombo IA, Filho GB. [Reduced fasting time improves comfort and satisfaction of elderly patients undergoing anesthesia for hip fracture]. Rev Bras Anestesiol. 2015 Mar-Apr;65(2):117-23. doi: 10.1016/j.bjan.2013.10.017. Epub 2014 Sep 26. Portuguese.

  PMID: 25740278 RESULT

• Ertural F, Kucukakca Celik G, Ozcelik H. Effect of Oral Carbohydrate Solution Administered Before Hip Arthroplasty on Preoperative Anxiety and Postoperative Patient Comfort: A Randomized Controlled Trial. J Perianesth Nurs. 2023 Jun;38(3):461-468. doi: 10.1016/j.jopan.2022.08.012. Epub 2023 Feb 16.

  PMID: 36803737 DERIVED

MeSH Terms

Conditions

Fasting; Anxiety Disorders

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Mental Disorders

Study Officials

• Gülden Küçükakça Çelik, Phd

  Nevşehir Hacı Bektaş Veli University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: randomized controlled clinical trial

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 24, 2021
• Study Start: September 11, 2019
• Primary Completion: August 27, 2021
• Study Completion: August 27, 2021
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)