Constipation Clinical Trial
Official title:
The Effect of Abdominal Massage Applied After Surgery on Gastrointestinal Symptoms and Comfort Level
This research is carried out by research assistant Semiha Kurt under the supervision of Associate Professor Nuray TURAN. In this research aimed to examine the effect of abdominal massage applied after surgical ıntervention on gastrointestinal symptoms and comfort level. The type of this study designed as randomized controlled experimental. The research hypotheses are as follows; H1: Abdominal massage applied after surgery reduces the gastrointestinal symptoms of patients. H2: Abdominal massage applied after surgery increases the comfort level of patients. The population of the research will consist patients who were hospitalized and underwent surgical intervention between January 2023 and July 2024 in the Orthopedics and Traumatology Clinic of the Istanbul Medical Faculty Hospital in Istanbul.The sample of the research will consist patients who cannot defecate for 3 days after surgery and who meet other sample selection criteria. As a result of the power analysis (G*Power 3.0.10); at least 34 samples found to be sufficient for each group with f=0.20 effect size, 90% power and 5% margin of error (n1:34, n2:34). The number of samples determined as 68 (including the experimental and control groups). Data will be collected through the Patient Information Form, Bristol Stool Scale, Gastrointestinal Symptom Rating Scale, General Comfort Scale, and Functional Independence Scale. The patient information form was prepared by the researchers in line with the literature. Permission was obtained from the scale owners for the scales to be used in the study. In the implementation phase of the research; in the formation of the experimental and control groups, the assignment of the patients to the experimental and control groups will be provided by randomization in the computer. Abdominal massage will be applied to the patients in the experimental group twice a day, in the morning and evening, for 3 days. Each abdominal massage will be applied for 15 minutes. The routine practice of the clinic will continue in the patients in the control group. Institutional permission from Istanbul Medical Faculty and ethics committee approval (Number: E-74555795-050.01.04-412448) from Istanbul University-Cerrahpasa Non-Interventional Research Ethics Committee obtained in order to conduct the study. Statistical analysis of research data will be done using a package program called SPSS (IBM SPSS Statistics 24). The expenses of the research will be covered by the researcher.
Status | Recruiting |
Enrollment | 68 |
Est. completion date | August 1, 2023 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years of age and above, - Being conscious and cooperative, - Being able to read, write and speak Turkish, not have any cognitive, sensory and spiritual problems, - Not being pregnant, - The vital signs are within normal limits after the surgical intervention, - Failure to defecate for the first 3 days after the surgical intervention, - Not using pharmacological and non-pharmacological agents with laxative effect after the surgical intervention, - Continuing inpatient care and treatment in the orthopedics and traumatology clinic for at least 6 days, - His willingness and volunteering to participate in the study was included. Exclusion Criteria: - Be less than 18 years old, - Not knowing how to read, write and speak Turkish, - Having any cognitive, sensory and spiritual problems, - Presence of conditions that prevent the application of abdominal massage (hernia, bowel cancer, history of abdominal surgery and Myocardial Infarction (MI), presence of ileostomy or colostomy and bleeding, etc.), - Being pregnant - The vital signs are not within normal limits after the surgical intervention, - Defecation in the first 3 days after the surgical intervention and using any pharmacological or non-pharmacological agent with laxative effect in this process, Continuing inpatient care and treatment in the orthopedics and traumatology clinic for less than 6 days, - Not willing to participate in the study. |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul University | Istanbul |
Lead Sponsor | Collaborator |
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Istanbul University |
Turkey,
1. Abd-El-Maeboud KHI, Ibrahim MI, Shalaby DAA, Fikry MF. (2009). Gum chewing stimulates early return of bowel motility after caesarean section. BJOG An International Journal of Obstetrics and Gynaecology, 116:1334-1339. 2. Bozkirli BO, Gündogdu RH, Ersoy PE, Akbaba S, Temel H, Sayin T. (2012). ERAS protokolü kolorektal cerrahi sonuçlarimizi etkiledi mi? Ulusal Cerrahi Dergisi, 28(3):149-155. doi:10.5152/UCD.2012.05. 3. Çam HH, Nur N.(2015). Hemsirelik ve ebelik ögrencilerinde algilanan stres ile gastrointestinal semptomlar arasindaki iliski. TAF Preventive Medicine Bulletin, 14(6): 475-482. 4. Çilingir M, Çifter Ç, Kiliçaslan RL. (2004). Mide kanserlerinde ameliyat sonrasi erken dönemde enteral ve parenteral beslenme yöntemlerinin morbidite ve mortalite üzerine etkileri. Demet Saglik Bilimsel Tip Dergisi, 2(6): 50-54. 5. Herce JL. (2009). Gastrointestinal complications in critically ill patients: What differs between adults and children? Curr Opin Clin Nutr Metab Care, 12(2): 180-185. 6. Kaçmaz Z, Kasikçi M. (2007). Effectiveness of bran supplement in older orthopaedic patients with constipation. Journal of Clinical Nursing, 16(5): 928-936. 7. Kanbir, O. (1998). Klasik Masaj. Bursa: Ekin Kitabevi Yayinlari, 189-193. 8. Kaya H, Kaya N, Turan N, Sirin K, Güloglu S. (2013). Identifying constipation risk in neurosurgery patients. Pielegniarstwo Neurologiczne iNeurochirurgiczne, 2(3): 96-103. 9. Kolcaba, K. (2003). Comfort Theory And Practice: A vision for holistic health care and research. Springer Publishing Co, New York, 37-58. 10. Kuguoglu S, Karabacak, Ü. (2008). Genel Konfor Ölçeginin Türkçe'ye uyarlanmasi. Florence Nightingale Hemsirelik Dergisi, 16(61), 16-23. 11. Kyle G. (2008). A proactive approach to the treatment of constipation. Continence, 2(4): 36-44. 12. Kyle, G. (2011). Managing constipation in adult patients. Nurse Prescribing, 9(10): 482-490. 13. Lamas K, Lindholm L, Stenlund H, Engström B, Jacobsson C. (2009). Effects of abdominal massage in management of constipation-A randomized controlled trial. International Journal of Nursing Studies.46(6): 759-767. 14. Lee EY, Mun MS, Lee SH, Cho SM (2011). Perceived stress and gastrointestinal symptoms in nursing students in Korea: A cross sectional survey. BMC Nursing, 10(22): 1-8. 15. McClurg D, Hagen S, Dickinson L. (2011). Abdominal massage for the treatment of constipation. Cochrane Database of Systematic Reviews, 4: 1-5. 16. Perez M, Martinez A. (2009) The Bristol scale - a useful system to assess stool form. Rev Esp EnfermDig. 101(5): 305-311. 17. Resedence TL, Brocklehurst JC. O'Neil PA. (1993). A pilot study on the effect of exercise and abdominal massage on bowel habit in continuing care patients. Clinical Rehabilitation, 7: 204-209. 18. Revicki DA, Wood M, Wiklund I, Crawley J. (1998). Reliability and validity of the gastrointestinal symptom rating scale in patients with gastroesophageal reflux disease. Quality of Life Research, 7: 75-83. 19. Suarez K, Mayer C, Ehlert U, Nater UM. (2010). Psychological stress and self-reported functional gastrointestinal disorders. J Nerv Ment Dis, 198(3): 226-229. 20. Tasdemir N. (2005). Hastalarin cerrahi girisim sonrasi abdominal distansiyona yönelik deneyimleri. Hacettepe Üniversitesi Saglik Bilimleri Enstitüsü Cerrahi Hemsireligi, Yüksek Lisans Tezi, Ankara. 21. Tuna N. (2011). A'dan Z'ye Masaj. (6.Baski). Istanbul: Nobel Tip Kitabevi, 17-39. 22. Turan N, Asti TA, Kaya N. (2017). Reliability and Validity of the Turkish Version of the Gastrointestinal Symptom Rating Scale. Gastroenterology Nursing, 40(1):47-55. 23. Turan N, Asti TA, Kaya N. (2017). Nörosirürji yogun bakim ünitesinde yatan hastalarda konstipasyon ve hemsirelik bakimi. Hemsirelikte Egitim ve Arastirma Dergisi, 14 (1): 73-78. 24. Turan N, Asti TA. (2016). The effect of abdominal massage on constipation and quality of life. Gastroenterology Nursing, 39(1):48-59. 25. Turan N, Asti T. (2015). Konstipasyon yönetiminde abdominal masajin önemi. Anadolu Hemsirelik ve Saglik Bilimleri Dergisi, 18(2): 148-154. 26. Ucuzal M, Aldanmaz N. (2015). Genel cerrahi hastalarinda ameliyat sonrasi konstipasyon riski. Inönü Üniversitesi Saglik Bilimleri Dergisi, 4 (2): 17-22. 27. Uysal N. (2010). Aralikli enteral beslenen hastalarda abdominal masajin gastrik rezidüel volüm ve komplikasyonlarina etkisi. Dokuz Eylül Üniversitesi Hemsirelik Yüksekokulu Hemsirelik Esaslari Anabilim Dali, Doktora Tezi, Izmir. 28. Wiesen P, Van Gossum A, Pereiser JC. (2006). Diarrhoea in the critical ill. Current Opinion in Critical Care, 2(2):149-154. 29. Abdominal cerrahi girisim uygulanan hastalarda görülen erken dönem sorunlari ve bu sorunlara yönelik hemsirelik uygulamalari. Hacettepe Üniversitesi Saglik Bilimleri Fakültesi Hemsirelik Dergisi, 2011; 18(2): 36-46. 30. Ari M, Yilmaz E. (2016). Ameliyat öncesi anksiyetenin ameliyat sonrasi konstipasyona etkisi. Turk J Colorectal Dis, 2:39-46.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gastrointestinal Symptom Rating Scale | It is divided into five sub-dimensions: abdominal pain, reflux, diarrhea, indigestion, and constipation. The scale includes 15 items, each scored on a seven-point Likert-type scale, with values ranging from "no discomfort" to "very severe discomfort". Higher scores on the scale indicate more severe symptoms. | Change in gastrointestinal symptoms at 6 days | |
Primary | General Comfort Scale | Evaluates the state of reaching the expected comfort increase result. The scale is scored on a four-point Likert-type scale, each ranging from "strongly agree" to "strongly disagree". The lowest score that can be obtained from the scale is 48, the median score is 120, and the highest score is 192. As the score obtained from the scale increases, the level of comfort perceived by the patient increases. | Change in comfort level in 6 days | |
Secondary | Functional Independence Scale | It is an assessment tool used to evaluate the functional status of individuals. Self-care (42 points), sphincter control (14 points), transfer (21 points), movement (14 points), communication (14 points) and social perception (21 points) 6 categories and a total of 18 activities are evaluated. Scale scores range from 18 to 126. A 7-point scale is used for each activity. If the total score is 36 points or less, it is defined as high, between 37-72 points as moderate, and 73 points and above as low disability. | Baseline | |
Secondary | Bristol Stool Scale | It will be used to evaluate the individual's first stool. Forms of feces found on the scale; Type 1 - Goat dung-like, lumpy and chunky hard stool Type 2 - Larger and combined agglomeration Type 3 - Less thick, softer stool with shallow cracks on the surface Type 4 - Stool with a smooth, slippery surface and a soft consistency Type 5 - Pieces of excrement with a consistency to give an edge Type 6 - Soft viscous, more water content, piecemeal stool Type 7 - Hard or soft, watery stool with no solid stool content | Up to 6 days after surgery | |
Secondary | Patient Information | It was created by the researcher based on the literature. It consists of two parts, individual and disease characteristics of the patients. In the first part; In the second part, individual characteristics such as age, gender, Body Mass Index (BMI), marital status, education level, health insurance, income level, history of surgical intervention, type of surgery and anesthesia applied, toilet habits, gastrointestinal problems, diet, nutrition habits and exercise status, first gas and stool removal time, initiation of oral intake and mobilization status. In the last part of the form, there is a table in which the bowel sounds measured during the patient follow-up will be recorded. | Baseline |
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