NCT05750186

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

9 months

First QC Date

February 3, 2023

Last Update Submit

February 20, 2023

Conditions

Keywords

Abdominal MassagePostoperative CareNonpharmacological MethodsIndependent Nursing Practices

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Functional Independence Scale

    Baseline

  • Bristol Stool Scale

    Up to 6 days after surgery

  • Patient Information

    Baseline

Study Arms (2)

Abdominal Massage Group

EXPERIMENTAL

At the first encounter with the patient; Patient Information Form, Gastrointestinal Symptom Rating Scale, General Comfort Scale and Functional Independence Scale will be applied. * From the morning of the first day, abdominal massage will be applied to the patients 2 times a day, in the morning and in the evening, for 3 days (15 minutes). * Then, applying abdominal massage to the patients in the experimental group. After each massage application, the patient's bowel sounds/movements will be listened to. * Medicines such as laxatives, suppositories and enemas will not be given to the experimental group and Bristol Stool Scale will be filled in for patients who defecate within this period. * In order to evaluate the abdominal massage and its effect on the comfort level of the patients, the Gastrointestinal Symptom Rating Scale, General Comfort Scale and Functional Independence Scale will be applied again at the end of the 3rd day after the application of abdominal massage.

Other: Abdominal Massage

Control Group

NO INTERVENTION

* Patients who did not defecate within the first 3 days after surgery will constitute the control group. * At the first encounter with the patient; A Patient Information Form, Gastrointestinal Symptom Rating Scale (GSS), General Comfort Scale (GAS) and Functional Independence Scale (FIM) will be administered. * From the first encounter, patients will be given medications that are in line with their clinical routine, such as laxatives, suppositories and enemas, according to the doctor's request. * Intestinal sounds/movements of the patients will be listened to 6 times, 2 times a day for 3 days. * Bristol Stool Scale will be filled in for patients who defecate within this period. * At the end of the 3-day follow-up of the patients, Gastrointestinal Symptom Rating Scale, General Comfort Scale and Functional Independence Scale will be applied again and the first stool of the patients who defecate will be evaluated with the Bristol Stool Scale.

Interventions

Abdominal massage is a noninvasive application that stimulates bowel movements by applying patting, kneading and vibration movements over the abdominal wall to the area where the intestines are located. It increases peristalsis, creates a mechanical and reflex effect on the intestines, reducing the individual's feeling of pain and discomfort.

Abdominal Massage Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Istanbul, 34116, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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. Bozkırlı BO, Gündoğdu RH, Ersoy PE, Akbaba S, Temel H, Sayın T. (2012). ERAS protokolü kolorektal cerrahi sonuçlarımızı etkiledi mi? Ulusal Cerrahi Dergisi, 28(3):149-155. doi:10.5152/UCD.2012.05. 3. Çam HH, Nur N.(2015). Hemşirelik ve ebelik öğrencilerinde algılanan stres ile gastrointestinal semptomlar arasındaki ilişki. TAF Preventive Medicine Bulletin, 14(6): 475-482. 4. Çilingir M, Çifter Ç, Kılıçaslan RL. (2004). Mide kanserlerinde ameliyat sonrası erken dönemde enteral ve parenteral beslenme yöntemlerinin morbidite ve mortalite üzerine etkileri. Demet Sağlık Bilimsel Tıp Dergisi, 2(6): 50-54. 5. Herce JL. (2009). Gastrointestinal complications in critically ıll patients: What differs between adults and children? Curr Opin Clin Nutr Metab Care, 12(2): 180-185. 6. Kaçmaz Z, Kaşıkçı 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 Yayınları, 189-193. 8. Kaya H, Kaya N, Turan N, Şirin K, Güloğlu S. (2013). Identifying constipation risk in neurosurgery patients. Pielęgniarstwo 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. Kuğuoğlu S, Karabacak, Ü. (2008). Genel Konfor Ölçeğinin Türkçe'ye uyarlanması. Florence Nightingale Hemşirelik 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. Taşdemir N. (2005). Hastaların cerrahi girişim sonrası abdominal distansiyona yönelik deneyimleri. Hacettepe Üniversitesi Sağlık Bilimleri Enstitüsü Cerrahi Hemşireliği, Yüksek Lisans Tezi, Ankara. 21. Tuna N. (2011). A'dan Z'ye Masaj. (6.Baskı). İstanbul: Nobel Tıp 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, Aştı TA, Kaya N. (2017). Nöroşirürji yoğun bakım ünitesinde yatan hastalarda konstipasyon ve hemşirelik bakımı. Hemşirelikte Eğitim ve Araştırma Dergisi, 14 (1): 73-78. 24. Turan N, Aştı TA. (2016). The effect of abdominal massage on constipation and quality of life. Gastroenterology Nursing, 39(1):48-59. 25. Turan N, Aştı T. (2015). Konstipasyon yönetiminde abdominal masajın önemi. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 18(2): 148-154. 26. Ucuzal M, Aldanmaz N. (2015). Genel cerrahi hastalarında ameliyat sonrası konstipasyon riski. İnönü Üniversitesi Sağlık Bilimleri Dergisi, 4 (2): 17-22. 27. Uysal N. (2010). Aralıklı enteral beslenen hastalarda abdominal masajın gastrik rezidüel volüm ve komplikasyonlarına etkisi. Dokuz Eylül Üniversitesi Hemşirelik Yüksekokulu Hemşirelik Esasları Anabilim Dalı, Doktora Tezi, İzmir. 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 girişim uygulanan hastalarda görülen erken dönem sorunları ve bu sorunlara yönelik hemşirelik uygulamaları. Hacettepe Üniversitesi Sağlık Bilimleri Fakültesi Hemşirelik Dergisi, 2011; 18(2): 36-46. 30. Arı M, Yılmaz E. (2016). Ameliyat öncesi anksiyetenin ameliyat sonrası konstipasyona etkisi. Turk J Colorectal Dis, 2:39-46.

    BACKGROUND
  • Kucukaydinoglu S, Turan N. The effect of abdominal massage applied after surgery on gastrointestinal symptoms and comfort level. Perioper Med (Lond). 2025 Aug 7;14(1):84. doi: 10.1186/s13741-025-00560-6.

MeSH Terms

Conditions

Gastroesophageal RefluxAbdominal PainConstipationDiarrheaDyspepsia

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Central Study Contacts

Semiha KURT Research Assistant, Master

CONTACT

Nuray TURAN Associate Professor, doctorate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 3, 2023

First Posted

March 1, 2023

Study Start

October 1, 2022

Primary Completion

July 1, 2023

Study Completion

August 1, 2023

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations