Clinical trial NCT04979351: The Effect of Post Colonoscopy Abdominal Massage on Abdominal Pain, Distension, Discomfort and Patient Satisfaction
Official title: The Effect of Post Colonoscopy Abdominal Massage on Abdominal Pain, Distension, Discomfort and Patient Satisfaction: a Randomized Controlled Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Colonoscopy
abdominal massage
abdominal pain
abdominal distension
abdominal discomfort
patient satisfaction
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Abdominal pain, distension, and discomfort are the most frequently seen side effects after colonoscopy. These side effects can cause physical and mental results and increased workloads and care costs. Additionally, the satisfaction of the patients with the colonoscopy process may affect their willingness to undergo repeated colonoscopies in the future which may be required for the surveillance of colon malignity. Currently, there are no studies evaluating the effects of abdominal massage on post colonoscopy these abdominal symptoms. The aim of this study was to evaluate the effect of post colonoscopy abdominal massage on abdominal pain, distension, discomfort, and patient satisfaction.

Methods: This study was designed as a prospective randomized controlled study. Participants meeting inclusion criteria will be assigned to intervention and control groups using a random number generator. Participants assigned to the intervention group will receive abdominal massages twice a day after colonoscopy, and participants assigned to the control group will receive only "routine care". The abdominal pain, distension, discomfort, and satisfaction levels of the patients will be evaluated using the Visual Analogue Scale.

Conclusions: New approaches are needed to improve the physiological and psychological health levels of patients after colonoscopy and help them return to their daily life activities and social lives faster. The trial will provide valuable evidence to inform clinical application and help evaluate the effects of the use of the relevant intervention.

Detailed description: Abdominal pain, bloating, and discomfort are the most frequently problems experienced by patients undergoing colonoscopy. These problems are thought to be caused by several factors such as the duration of the process, the technical difficulty level of the process, distension caused by air insufflation, and the expertise level of the endoscopist. These problems are experienced by approximately a third of patients undergoing colonoscopy, and may last from a few hours to a few days. In a recent study, 44% of patients were found to experience such minor side effects 24 hours after colonoscopy, and 23% were found to experience them after a 30 day follow up. Although these problems are dubbed minor side effects, they may cause serious results for patients with regard to physical comfort and mental stress and may necessitate patients to be monitored post colonoscopy and followed up closely. This may lead to an increase in costs by increasing the length of hospital stay and nursing care requirements. Additionally, the satisfaction of the patients with the colonoscopy process may affect their willingness to undergo repeated colonoscopies in the future which may be required for the surveillance of colon malignity. For these reasons, decreasing post colonoscopy abdominal pain, distension, and discomfort and increasing patient satisfaction may increase the acceptance of future colonoscopy screening for colorectal cancers.

Studies focused on decreasing abdominal symptoms after colonoscopy and increasing patient comfort and satisfaction have yielded varying results. For example, while some studies have reported that rectal tube application after colonoscopy reduces pain and increases patient comfort and satisfaction, in another study, it was determined that rectal tube application post colonoscopy had no effect on abdominal distension, pain, discomfort, and patient satisfaction after the process and 24 hours later. In another study, rectal aspiration applied right after colonoscopy was found to be more effective in decreasing abdominal symptoms compared to the application of rectal tubes after colonoscopy. In another study where total colonic decompression through repeating cecal intubation after colonoscopy was applied, the method was found to decrease the distension complaints of patients in the early post colonoscopy period from 59% to 25%. However, in this study, no significant difference between the groups that did and did not receive decompression with regard to abdominal pain and distension could be found 24 to 48 hours after the procedure. In yet another study, no significant difference with regard to pain intensity could be found between the aspiration of air in the curves of the colon without repeated intubation while the colonoscope was being taken out and rectal aspiration.

Abdominal massaging has been shown to help improve symptoms in patients with severe constipation. In the literature, it has been reported that abdominal massage relaxes the abdominal muscles and stimulates the excretory activity by supporting the intestine, decrease discomfort and pain in individuals with abdominal pain related to cramps or flatulence, and increase the quality of life. Moreover, it is a non-invasive and safe non-pharmacological method. It has no known side effects and does not require any cost.

In this study, it was assumed post-colonoscopy abdominal massage can improve their abdominal symptoms. However, to date, there is no study evaluating the effects of abdominal massage on abdominal symptoms after colonoscopy. Therefore, a prospective study was designed to evaluate the aspect of post-colonoscopy abdominal massage that concerns endoscopy nurses, namely its effect on abdominal pain, bloating, discomfort and patient satisfaction.

Aim

The aim of this study was to evaluate the effect of post colonoscopy abdominal massage on abdominal pain, distension, discomfort, and patient satisfaction.

Null hypothesis

There will be no significant difference between patients receiving abdominal massage post colonoscopy and those not receiving such an intervention with regard to abdominal pain, distension, discomfort, and patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* being of 18 years of age and above
* owning a cell phone
* having a body mass index below 30
* being conscious and having location
* people, and time orientation
* having no communication barriers
* being able to communicate in Turkish
* giving written informed consent to participate in the study

Exclusion Criteria:

* were receiving sedation
* having previously received intestine resection or other intestinal surgery
* having an uncontrolled psychopathological illness
* receiving colonoscopy for treatment
* having active lower gastrointestinal system bleeding

Primary outcomes:
measure: Abdominal pain
timeFrame: The end of the second day.
Secondary outcomes:
measure: Abdominal distension
timeFrame: The end of the second day.
Other outcomes:
measure: Comfort
timeFrame: The end of the second day.
measure: High Satisfaction
timeFrame: The end of the second day.
Locations:
city: Istanbul
country: Turkey
facility: Prof. Dr. Cemil Taşcıoğlu City Hospital
Study officials:
affiliation: specify Unaffiliated
name: DİLEK ÖZTÜRK, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: specify Unaffiliated
name: Aysel GÜRKAN, PhD
role: STUDY_DIRECTOR
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