Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05823350 |
| Other study ID # |
TUTF-BAEK 2019/293 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 15, 2019 |
| Est. completion date |
September 15, 2022 |
Study information
| Verified date |
April 2023 |
| Source |
Trakya University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Aim: This study aimed to evaluate the effect of abdominal massage on pain and distention in
patients who underwent colonoscopy.
Methods: This randomized controlled study was conducted between October 2019 and December
2021 with the participation of 60 patients who underwent colonoscopy in the endoscopy unit of
a university hospital. Thirty patients performing abdominal massage after colonoscopy were
included in the experimental group.
Description:
Aim: This study aimed to evaluate the effect of abdominal massage on pain and distention in
patients who underwent colonoscopy.
Methods:
Settings and Design This randomized controlled experimental study was conducted between
September 2019 and September 2022 with the participation of 60 patients who underwent
colonoscopy in the endoscopy unit of a university hospital.
The patients who underwent elective total colonoscopy, were accompanied by an attendant
before and after the procedure, had an ASA score of ≤ 2, had no problem that would prevent
the application of abdominal massage (past abdominal surgery, irritable bowel disease,
diagnosis of bowel cancer, gastrointestinal or urinary ostomy, etc.), and accepted the
application of abdominal massage after the procedure, were included in the study.
Patients who did not speak Turkish or didn't have any attendant who could speak Turkish, who
did not want to receive abdominal massage, who couldn't learn abdominal massage or did not
want to do it, and the patients for whom the procedure was not fully implemented due to
reasons such as insufficient bowel preparation, were excluded from the study.
During the study's follow-up period, no complications related to colonoscopy were observed in
the participating patients.
Data Collection Tools Patient information form and patient follow-up form were used for
collecting research data. The patient information form included 3 questions investigating the
sociodemographic characteristics of the patients (age, gender, experience of colonoscopy).
The patient follow-up form contains four questions including the patients' pain and
distension level after colonoscopy and abdominal massage. The level of pain and distension
was evaluated with a 0-10 numerical comparison scale (Dreyer ve ark. 2015).
Data Collection The number of patients in each group was determined to be equal (30:30) by
randomization carried out through the computer program called Research Randomiser. The group
that received abdominal massage was accepted as the experimental group. On the day of the
procedure, all patients who came to the endoscopy unit for a total colonoscopy were informed
by the researcher about the study and then written and verbal informed consents were obtained
from the patients.
In the control group, after the procedure, one relative was allowed to accompany each patient
who was taken to the care room after the endoscopy. The patients who were taken to their beds
were asked to evaluate their pain and distension levels after the colonoscopy (first
evaluation). The initial pain and distension levels after the procedure were recorded on the
form by the researcher. The vital signs of the patients who received standard care were
monitored after the procedure and were followed up for possible complications. The pain and
distension levels of the patients were evaluated again 20 minutes after the first assessment
(second evaluation). After the procedure, patients who met the discharge criteria were given
discharge training and they were allowed to leave the endoscopy unit after the vascular
access catheter was removed.
In the experimental group, the relatives of the patients were shown the video in the
preparation room before the colonoscopy. The video consisted of visual and verbal content
about the definition, purposes, application, and importance of the colonoscopy, the purpose
of insufflation, pain management during and after the procedure, and the benefits and
application steps of abdominal massage in pain management after the procedure. The video
lasted 3 minutes and 19 seconds.
After the procedure, a relative was allowed to accompany each of the experimental group
patients who were taken to the care room after the endoscopy. The patients who were taken to
their beds were asked to evaluate their pain and distension levels after the colonoscopy
(first evaluation). The initial pain and distension levels after the procedure were recorded
on the form by the researcher. Afterwards, the relatives of the patients in the experimental
group were asked to apply abdominal massage to their patients. During the massage
application, the patient and their relatives were observed by the researcher, and when
necessary, guidance was given to the patient's relatives about the application of the
massage. Liquid vaseline was used to ensure the slipperiness of the hands during the massage.
In this supine position, patient's abdomen was massaged with circular movements and different
techniques (kneading, vibration, efflorescence, superficial or deep strokes) in the direction
of the colon.
As suggested in the literature, an abdominal massage lasted 15 minutes (Yıldırım et al.
2019). When necessary, verbal and visual guidance was provided by the researcher to ensure
that the massage was performed with the correct steps and for the required time.After 5
minutes after the massage application, the researcher evaluated the patients' pain and
distension levels and recorded the data on the form (second evaluation; 20 minutes after the
first evaluation). After the procedure, patients who met the discharge criteria were given
discharge training and they were allowed to leave the endoscopy unit after the vascular
catheter was removed.
Statistical Analysis Data obtained from sixty-five patients were analyzed using the IBM SPSS
22.0 (IBM, Armonk, New York, USA) package program. Normal distribution was determined by the
Kolmogorov-Smirnov test. The Mann-Whitney U test was used to compare the pain and distention
scores between the two groups. Wilcoxon Signed rank test was used to compare the means of
pain and distention scores within the group. The statistical significance level was accepted
as p < 0.05.
