The Effect of Post Colonoscopy Abdominal Massage on Abdominal Pain, Distension, Discomfort and Patient Satisfaction
Primary Purpose
Healthy
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Abdominal Massage
Sponsored by
About this trial
This is an interventional prevention trial for Healthy focused on measuring Colonoscopy, abdominal massage, abdominal pain, abdominal distension, abdominal discomfort, 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
Sites / Locations
- Prof. Dr. Cemil Taşcıoğlu City Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Abdominal Massage Group
Placebo Group
Arm Description
Abdominal massage for 15 minutes twice a day application.
Abdominal massage was not applied.
Outcomes
Primary Outcome Measures
Abdominal pain
Abdominal pain will be evaluated with the Visual Analog Scale Zero = minimum value Ten = maximum value
Secondary Outcome Measures
Abdominal distension
Abdominal distension will be evaluated with the Visual Analog Scale Zero = minimum value Ten = maximum value
Full Information
NCT ID
NCT04979351
First Posted
July 10, 2021
Last Updated
July 30, 2021
Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
1. Study Identification
Unique Protocol Identification Number
NCT04979351
Brief Title
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Colonoscopy, abdominal massage, abdominal pain, abdominal distension, abdominal discomfort, patient satisfaction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abdominal Massage Group
Arm Type
Experimental
Arm Description
Abdominal massage for 15 minutes twice a day application.
Arm Title
Placebo Group
Arm Type
No Intervention
Arm Description
Abdominal massage was not applied.
Intervention Type
Other
Intervention Name(s)
Abdominal Massage
Intervention Description
Abdominal massage will be applied twice a day.
Primary Outcome Measure Information:
Title
Abdominal pain
Description
Abdominal pain will be evaluated with the Visual Analog Scale Zero = minimum value Ten = maximum value
Time Frame
The end of the second day.
Secondary Outcome Measure Information:
Title
Abdominal distension
Description
Abdominal distension will be evaluated with the Visual Analog Scale Zero = minimum value Ten = maximum value
Time Frame
The end of the second day.
Other Pre-specified Outcome Measures:
Title
Comfort
Description
Abdominal comfort will be evaluated with the Visual Analog Scale Zero = minimum value Ten = maximum value
Time Frame
The end of the second day.
Title
High Satisfaction
Description
Patient satisfaction will be evaluated with the Visual Analog Scale Zero = minimum value Ten = maximum value
Time Frame
The end of the second day.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DİLEK ÖZTÜRK, MSc
Organizational Affiliation
specify Unaffiliated
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aysel GÜRKAN, PhD
Organizational Affiliation
specify Unaffiliated
Official's Role
Study Director
Facility Information:
Facility Name
Prof. Dr. Cemil Taşcıoğlu City Hospital
City
Istanbul
ZIP/Postal Code
34384
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study results will be shared.
IPD Sharing Time Frame
No time limit
IPD Sharing Access Criteria
No Access Criteria
Citations:
PubMed Identifier
21455041
Citation
Devitt J, Shellman L, Gardner K, Nichols LW. Using positioning after a colonoscopy for patient comfort management. Gastroenterol Nurs. 2011 Mar-Apr;34(2):93-100. doi: 10.1097/SGA.0b013e31820f9ac3.
Results Reference
background
PubMed Identifier
30670909
Citation
Kim SY, Kim HS, Park HJ. Adverse events related to colonoscopy: Global trends and future challenges. World J Gastroenterol. 2019 Jan 14;25(2):190-204. doi: 10.3748/wjg.v25.i2.190.
Results Reference
background
PubMed Identifier
25946475
Citation
Lynch I, Hayes A, Buffum MD, Conners EE. Insufflation using carbon dioxide versus room air during colonoscopy: comparison of patient comfort, recovery time, and nursing resources. Gastroenterol Nurs. 2015 May-Jun;38(3):211-7. doi: 10.1097/SGA.0000000000000109.
Results Reference
background
PubMed Identifier
15895308
Citation
Liu Z, Sakakibara R, Odaka T, Uchiyama T, Yamamoto T, Ito T, Hattori T. Mechanism of abdominal massage for difficult defecation in a patient with myelopathy (HAM/TSP). J Neurol. 2005 Oct;252(10):1280-2. doi: 10.1007/s00415-005-0825-9. Epub 2005 May 20. No abstract available.
Results Reference
background
PubMed Identifier
23161296
Citation
Arabul M, Kandemir A, Celik M, Alper E, Akpinar Z, Aslan F, Vatansever S, Unsal B. Impact of an information video before colonoscopy on patient satisfaction and anxiety. Turk J Gastroenterol. 2012;23(5):523-9. doi: 10.4318/tjg.2012.0416.
Results Reference
background
PubMed Identifier
26827847
Citation
Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008. Erratum In: J Pain. 2016 Apr;17(4):508-10. Dosage error in article text.
Results Reference
background
PubMed Identifier
23720082
Citation
Ayan M, Tas U, Sogut E, Arici S, Karaman S, Esen M, Demirturk F. [Comparing efficiencies of diclofenac sodium and paracetamol in patients with primary dysmenorrhea pain by using Visual Analog Scale]. Agri. 2013;25(2):78-82. doi: 10.5505/agri.2013.42103. Turkish.
Results Reference
background
PubMed Identifier
11719741
Citation
Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001 Dec;38(6):633-8. doi: 10.1067/mem.2001.118863.
Results Reference
background
PubMed Identifier
16153776
Citation
Gagliese L, Weizblit N, Ellis W, Chan VWS. The measurement of postoperative pain: a comparison of intensity scales in younger and older surgical patients. Pain. 2005 Oct;117(3):412-420. doi: 10.1016/j.pain.2005.07.004.
Results Reference
background
PubMed Identifier
22472671
Citation
Uysal N, Eser I, Akpinar H. The effect of abdominal massage on gastric residual volume: a randomized controlled trial. Gastroenterol Nurs. 2012 Mar-Apr;35(2):117-23. doi: 10.1097/SGA.0b013e31824c235a.
Results Reference
background
PubMed Identifier
12188155
Citation
Preece J. Introducing abdominal massage in palliative care for the relief of constipation. Complement Ther Nurs Midwifery. 2002 May;8(2):101-5. doi: 10.1054/ctnm.2002.0610.
Results Reference
background
PubMed Identifier
30523730
Citation
Steffenssen MW, Al-Najami I, Zimmermann-Nielsen E, Baatrup G. Patient-reported complications related to colonoscopy: a prospective feasibility study of an email-based survey. Acta Oncol. 2019;58(sup1):S65-S70. doi: 10.1080/0284186X.2018.1535188. Epub 2018 Dec 7.
Results Reference
result
PubMed Identifier
12145595
Citation
Sumanac K, Zealley I, Fox BM, Rawlinson J, Salena B, Marshall JK, Stevenson GW, Hunt RH. Minimizing postcolonoscopy abdominal pain by using CO(2) insufflation: a prospective, randomized, double blind, controlled trial evaluating a new commercially available CO(2) delivery system. Gastrointest Endosc. 2002 Aug;56(2):190-4. doi: 10.1016/s0016-5107(02)70176-4.
Results Reference
result
PubMed Identifier
28056353
Citation
Erstad DJ, Krowsoski LS, Kaafarani HM. Abdominal Pain After Colonoscopy. Gastroenterology. 2017 Feb;152(3):486-487. doi: 10.1053/j.gastro.2016.08.060. Epub 2017 Jan 3. No abstract available.
Results Reference
result
PubMed Identifier
27651788
Citation
Yi CH, Liu TT, Lei WY, Hung JS, Chen CL. Influence of Rectal Decompression on Abdominal Symptoms and Anorectal Physiology following Colonoscopy in Healthy Adults. Gastroenterol Res Pract. 2016;2016:4101248. doi: 10.1155/2016/4101248. Epub 2016 Aug 29.
Results Reference
result
PubMed Identifier
27336061
Citation
Liu TT, Yi CH, Lei WY, Yu HC, Hung JS, Chen CL. Comparison of rectal suction versus rectal tube insertion for reducing abdominal symptoms immediately after unsedated colonoscopy. Endosc Int Open. 2016 Jun;4(6):E725-9. doi: 10.1055/s-0034-1392223. Epub 2015 Dec 15.
Results Reference
result
PubMed Identifier
9402119
Citation
Steinberg EN, Howden CW. Randomized controlled trial of rectal tube placement for the management of abdominal distension following colonoscopy. Gastrointest Endosc. 1997 Nov;46(5):444-6. doi: 10.1016/s0016-5107(97)70038-5.
Results Reference
result
PubMed Identifier
12518131
Citation
Hilzenrat N, Fich A, Odes HS, Krugliak P, Eidelman L, Gaspar N, Weisberg G, Rosenthal A, Delgado JL, Ginat R, Sperber AD. Does insertion of a rectal tube after colonoscopy reduce patient discomfort and improve satisfaction? Gastrointest Endosc. 2003 Jan;57(1):54-7. doi: 10.1067/mge.2003.47.
Results Reference
result
PubMed Identifier
11197295
Citation
Lee JG, Vigil H, Leung JW. A randomized controlled trial of total colonic decompression after colonoscopy to improve patient comfort. Am J Gastroenterol. 2001 Jan;96(1):95-100. doi: 10.1111/j.1572-0241.2001.03458.x.
Results Reference
result
PubMed Identifier
19217105
Citation
Lamas K, Lindholm L, Stenlund H, Engstrom B, Jacobsson C. Effects of abdominal massage in management of constipation--a randomized controlled trial. Int J Nurs Stud. 2009 Jun;46(6):759-67. doi: 10.1016/j.ijnurstu.2009.01.007. Epub 2009 Feb 12.
Results Reference
result
PubMed Identifier
21943617
Citation
Sinclair M. The use of abdominal massage to treat chronic constipation. J Bodyw Mov Ther. 2011 Oct;15(4):436-45. doi: 10.1016/j.jbmt.2010.07.007. Epub 2010 Aug 25.
Results Reference
result
PubMed Identifier
29389471
Citation
Dehghan M, Fatehi Poor A, Mehdipoor R, Ahmadinejad M. Does abdominal massage improve gastrointestinal functions of intensive care patients with an endotracheal tube?: A randomized clinical trial. Complement Ther Clin Pract. 2018 Feb;30:122-128. doi: 10.1016/j.ctcp.2017.12.018. Epub 2017 Dec 30.
Results Reference
result
PubMed Identifier
21520798
Citation
McClurg D, Lowe-Strong A. Does abdominal massage relieve constipation? Nurs Times. 2011 Mar 29-Apr 4;107(12):20-2.
Results Reference
result
PubMed Identifier
26310997
Citation
Kjeldsen HB, Klausen TW, Rosenberg J. Preferred Presentation of the Visual Analog Scale for Measurement of Postoperative Pain. Pain Pract. 2016 Nov;16(8):980-984. doi: 10.1111/papr.12344. Epub 2015 Aug 27.
Results Reference
result
PubMed Identifier
33179847
Citation
Altun Ugras G, Yuksel S, Isik MT, Tasdelen B, Dogan H, Mutluay O. Effect of abdominal massage on bowel evacuation in neurosurgical intensive care patients. Nurs Crit Care. 2022 Jul;27(4):558-566. doi: 10.1111/nicc.12575. Epub 2020 Nov 12.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Review
Available IPD/Information URL
https://dergipark.org.tr/tr/download/article-file/117117
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://dergipark.org.tr/tr/download/article-file/29524
Learn more about this trial
The Effect of Post Colonoscopy Abdominal Massage on Abdominal Pain, Distension, Discomfort and Patient Satisfaction
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