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Completed

NCT Number: NCT05127577

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

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

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mersin Univercity

Mersin, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Intra-abdominal Pressure Value

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

    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.

  2. Return time of bowel sounds

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

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

  3. Number of bowel sounds

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

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

  4. First defecation time

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

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

  5. Amount of laxative use

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

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

Secondary outcomes

  1. Pulmonary Function Tests- FVC

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

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

  2. Pulmonary Function Tests- FEV-1

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

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

  3. Pulmonary Function Tests- FEV1/FVC

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

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

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Official study title

Effect of Abdominal Massage on Excretory Activity and Pulmonary Function Tests in Patients With Partial Hip Replacement

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 19, 2021
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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