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CompletedNCT05127577Updated Mar 15, 2023

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

An interventional study of Abdominal massage in Intraabdominal Pressure, sponsored by Mersin University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2023-03-15.

Sponsored by Mersin University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

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

Read the detailed description

Methods: The research will be carried out with 78 patients who underwent partial hip replacement. Patients were assigned to study (abdominal massage) and control groups by randomization. Abdominal massage will be applied to the patients at least 30 minutes after the morning and evening meals (08:30 in the morning, 20:30 in the evening) for 15 minutes, similar to the literature. Patients' data will be collected 15 minutes before and after the application of abdominal massage. Within the scope of the patient's data, information on pulmonary function test values, intra-abdominal pressure value and excretory activities will be collected. 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. No treatment will be applied to the patients in the control group. The data recorded before and after the abdominal massage in the study group will be recorded in the Excretory Activity Form and the Pulmonary Function Test Form as a result of the measurements made at the same time in the control group.

02

Conditions studied

  • Intraabdominal Pressure

Keywords

  • Abdominal massage
  • Pulmonary function tests
  • Partial hip replacement
  • Nursing care
  • Excretory activity
  • Defecation
03

In context

Lead sponsor

Mersin University is the lead sponsor of 176 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
78 participants (actual)

Study arms

  • Experimental
    Abdominal massage group

    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

  • No intervention
    Control group

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

Interventions

  • OtherAbdominal massage

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to first defecation an average of 3 days

  2. Return time of bowel sounds

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

    Time frame: up to first defecation an average of 3 days

  3. Number of bowel sounds

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

    Time frame: up to first defecation an average of 3 days

  4. First defecation time

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

    Time frame: up to first defecation an average of 3 days

  5. 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.

    Time frame: up to first defecation an average of 3 days

Secondary outcomes

  1. Pulmonary Function Tests- FVC

    The FVC value obtained using the Respiratory Function Test device will be recorded in the Pulmonary Function Tests Form.

    Time frame: up to first defecation an average of 3 days

  2. Pulmonary Function Tests- FEV-1

    The FEV-1 value obtained using the Respiratory Function Test device will be recorded in the Pulmonary Function Tests Form.

    Time frame: up to first defecation an average of 3 days

  3. Pulmonary Function Tests- FEV1/FVC

    The FEV1/FVC value obtained using the Respiratory Function Test device will be recorded in the Pulmonary Function Tests Form.

    Time frame: up to first defecation an average of 3 days

07

Study locations

1 site
  • Mersin Univercity
    Mersin, Turkey (Türkiye)
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2021 to primary completion in Sep 2022, 9 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2021
First posted
Nov 19, 2021
StartActual
Dec 30, 2021
Primary completionActual
Sep 30, 2022
CompletionActual
Sep 30, 2022
Last update
Mar 15, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05127577
Lead sponsor
Mersin University
Responsible party
Canan KANAT (Research Assistant, Mersin University) — Principal investigator
First posted
Nov 19, 2021
Start date
Dec 30, 2021
Primary completion
Sep 30, 2022
Completion
Sep 30, 2022
Last update
Mar 15, 2023

Study contacts

Gülay Altun Uğraş, doctorate
study director · Mersin University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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