The Effect of Post Colonoscopy Abdominal Massage on Abdominal Pain, Distension, Discomfort and Patient Satisfaction

Healthy Clinical Trial

Official title:

The Effect of Post Colonoscopy Abdominal Massage on Abdominal Pain, Distension, Discomfort and Patient Satisfaction: A Randomized Controlled Study Protocol

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04979351
• Other study ID #: CemilTasciogluERHO
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 9, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: July 2021
• Source: Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: October 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain
• Healthy

Intervention

Other:
• Abdominal Massage
Abdominal massage will be applied twice a day.

Locations

Country	Name	City	State
Turkey	Prof. Dr. Cemil Tascioglu City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comfort	Abdominal comfort will be evaluated with the Visual Analog Scale Zero = minimum value Ten = maximum value	The end of the second day.
Other	High Satisfaction	Patient satisfaction will be evaluated with the Visual Analog Scale Zero = minimum value Ten = maximum value	The end of the second day.
Primary	Abdominal pain	Abdominal pain will be evaluated with the Visual Analog Scale Zero = minimum value Ten = maximum value	The end of the second day.
Secondary	Abdominal distension	Abdominal distension will be evaluated with the Visual Analog Scale Zero = minimum value Ten = maximum value	The end of the second day.