Effect of Abdominal Massage on Excretory Activity and Pulmonary Function Tests in Patients After Surgery

NCT05127577 | Completed DMC

• 1 other identifier: MersinUCKANAT-01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This study is aimed to determine the effect of abdominal massage on excretory activity and pulmonary function tests (PFT) in patients undergoing PKP.

Conditions

Intraabdominal Pressure

Keywords

Abdominal massage; Pulmonary function tests; Partial hip replacement; Nursing care; Excretory activity; Defecation

Outcome Measures

Primary Outcomes (5)

• Intra-abdominal Pressure Value

  Intra-abdominal pressure measurement will be performed using the existing urinary catheter in the patient. This measurement method, which is performed through the bladder, is accepted as the gold standard for intra-abdominal pressure measurement because it is an easy-to-apply and minimally invasive procedure \[25,43\]. The investigator (CK) will measure the intra-abdominal pressure via a sterile single-transducer pressure monitoring set, which will be attached to the patient's urinary catheter at one end and to a portable monitor capable of measuring pressure at the other end. The measured value will be recorded in Excretory Activities Form.

  up to first defecation an average of 3 days

• Return time of bowel sounds

  The return time of bowel sounds will be evaluated morning and evening and recorded in the Excretory Activities Form.

  up to first defecation an average of 3 days

• Number of bowel sounds

  The number of bowel sounds will be evaluated morning and evening and recorded in the Excretory Activities Form.

  up to first defecation an average of 3 days

• First defecation time

  The time to first defecation will be asked morning and evening after surgery and recorded in the Excretory Activities Form.

  up to first defecation an average of 3 days

• Amount of laxative use

  The amount of drug use to assist with defecation will be evaluated morning and evening and recorded in the Excretory Activities Form.

  up to first defecation an average of 3 days

Secondary Outcomes (3)

• Pulmonary Function Tests- FVC

  up to first defecation an average of 3 days

• Pulmonary Function Tests- FEV-1

  up to first defecation an average of 3 days

• Pulmonary Function Tests- FEV1/FVC

  up to first defecation an average of 3 days

Study Arms (2)

Abdominal massage group

EXPERIMENTAL

Abdominal massage will be applied to the experimental group 2 times a day, morning and evening, until defecation, starting in the evening of the first day after the surgical intervention.

Other: Abdominal massage

Control group

NO INTERVENTION

The control group will be received routine treatment and care in the unit.

Interventions

Abdominal massage OTHER

Abdominal massage will be applied to patients at least 30 minutes after morning and evening meals (8:30 in the morning, 20:30 in the evening) for 15 minutes each, similar to the literature \[33,34,38\]. Data of the patients will be collected again 15 minutes after the application of abdominal massage (09:00-09:15 in the morning, 21:00-21:15 in the evening). Abdominal massage will start in the evening of the day the patient is transferred to the clinic (20:30), and will be terminated when the patient defecates. In order to stimulate bowel movements, four basic movements will be used in the abdominal massage to be applied clockwise: superficial effusion, deep effusion, petrissage, and vibration.

Abdominal massage group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a urinary catheter for at least one day after surgery,
• Discharged at least 48 hours after surgery,
• Do not have any condition for which abdominal massage is contraindicated (inflammatory bowel disease, presence of abdominal tumor, surgical intervention or radiotherapy to the abdominal region, presence or suspicion of ileus, and pregnancy),
• No diagnosis of chronic constipation made by a physician,
• Who has not developed any respiratory tract complications (atelectasis, pneumonia, etc.) due to surgical intervention,
• No chronic respiratory disease (chronic obstructive pulmonary disease, pulmonary hypertension, sleep apnea syndrome, asthma, chronic bronchitis, cystic fibrosis, occupational lung diseases, etc.),
• Patients who do not have problems in transition to oral feeding and who can be fed orally will be included in the study.

You may not qualify if:

• Urinary catheter removed within the first day after surgery,
• Discharged before 48 hours after surgery,
• Any condition in which abdominal massage is contraindicated (inflammatory bowel disease, presence of abdominal tumor, surgical intervention or radiotherapy to the abdominal region, presence or suspicion of ileus, and pregnancy),
• Having a diagnosis of constipation made by a physician,
• Having any respiratory complications (atelectasis, pneumonia, etc.) developed due to surgical intervention,
• Having chronic respiratory disease (chronic obstructive pulmonary disease, pulmonary hypertension, sleep apnea syndrome, asthma, chronic bronchitis, cystic fibrosis, occupational lung diseases, etc.),
• Patients who have problems in the transition to oral feeding and cannot be fed orally will not be included in the study.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin Univercity

Mersin, Turkey (Türkiye)

Location

Study Officials

• Gülay Altun Uğraş, doctorate

  Mersin University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: According to the randomization table, the information showing the patients included in the research sample is assigned to the A and B groups will be put in an opaque envelope. This envelope will be kept by the coordinator researcher (GAU) and when the researcher (CK) goes to the patient for application, after filling out the "Informed Voluntary Consent Form", he will open the envelope and learn which group is in which group. Due to the nature of the study, patients and the researcher (CK) will not be blinded, since abdominal massage will be applied only to the patients included in the study. When the research is completed, the data will be transferred to the computer environment by a statistician who does not know the A and B groups, and the data will be analyzed by a statistician independent of the research and the findings will be reported. Thus, the data analysis and statistics phase will be blind to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Prospective, parallel, two-arm, randomized controlled clinical trial

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 19, 2021
• Study Start: December 30, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-03

Locations

TU (1)