Care Package for Postoperative Constipation (Car_Package)

April 30, 2024 updated by: Kubra KAYA

Background: Postoperative constipation is a common complication. The effectiveness of a care package constituting warm water intake, abdominal massage, and a high-fiber diet has not been investigated in patients undergoing orthopedic surgery.

Aim: the investigators determined the effects of a care package, including warm water intake, abdominal massage, and high-fiber diet, on constipation prevention, aiming to improve patient quality of life during the postoperative period and support nurses in clinical practice.

Study design: This was a single-center, randomized controlled trial of patients hospitalized in the Orthopedics and Traumatology Clinic of a state hospital between September 15, 2022, and April 30, 2023. Overall, 102 patients were randomly assigned to study and control groups. Routine clinical practice was maintained for patients in the control group, whereas a care package constituting postoperative warm water intake, abdominal massage, and a high-fiber diet was provided to those in the study group. Data was collected using the 'Constipation Risk Assessment Scale' and 'Visual Analog Scale'. Constipation severity was evaluated by administering the scales one day before surgery (T0) and one (T1), two (T2), three (T3), and four (T4) days postoperatively. Data were analyzed using SPSS software (version 20.0; IBM, Canada). Statistical significance was set at p < 0.05.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

INTRODUCTİON Constipation is a common complication observed in patients undergoing orthopedic surgery. The incidence of constipation is reported to be between 40-72% in these patients . Factors such as immobilization during the postoperative period, opioid use, addressing voiding and bowel movements in bed, pain, and inadequate intake of food and fluids contribute to increased susceptibility to constipation in patients undergoing orthopedic surgery. Prolonged immobilization of patients undergoing orthopedic surgery and the widespread use of opioid analgesics in pain management protocols can increase the frequency of constipation. Additionally, increased catecholamine release due to surgical stress is considered a cause for decreased bowel mobility, leading to constipation during the postoperative period.

Constipation can lead to multiple adverse effects in patients, such as discomfort, bloating, pain, loss of appetite, nausea, vomiting, and increased psychosocial stress. Prevention and reduction of constipation symptoms improve patient comfort and quality of life. Constipation in surgical patients increases the risk of postoperative complications and prolongs hospital stay .

Multiple studies have utilized non-pharmacological methods to prevent constipation. The effects of abdominal massage and a high-fiber diet were investigated in studies aimed at preventing constipation in patients undergoing orthopedic surgery. However, no study has investigated the effects of early warm water intake on constipation in patients undergoing orthopedic surgery. Nevertheless, one study found that patients administered warm water postoperatively experienced earlier bowel movements.

The benefits of implementing care packages have been reported; however, the literature on care packages aimed specifically at preventing constipation remains limited. Several existing care packages have been reported to be effective in preventing constipation . However, no study investigated the effects of a triple care package constituting early postoperative warm water intake, abdominal massage, and a high-fiber diet on constipation prevention in patients undergoing orthopedic surgery, and previous studies have focused on individual components of the investigated care package.

AIMS AND HYPOTHESİS We aimed to determine the effects of a three-intervention constipation prevention care package constituting early postoperative warm water intake, abdominal massage, and a high-fiber diet on the severity of postoperative constipation in patients undergoing orthopedic surgery. We aimed to improve patients' quality of life and to support nurses in clinical practice during the postoperative period. Our study contributes to the literature owing to the lack of studies that investigated the effects of the aforementioned care package on constipation prevention in patients undergoing orthopedic surgery.

The following hypotheses were tested in this study:

H11: The constipation prevention care package shortens the time to first defecation postoperatively in patients undergoing orthopedic surgery.

H12: The constipation prevention care package reduces postoperative constipation severity in patients undergoing orthopedic surgery.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Central
      • Gaziantep, Central, Turkey, 27100
        • Orthopedics and Traumatology Clinic of Abdulkadir Yüksel State Hospital in Gaziantep.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • aged ≥ 18 years,
  • undergoing elective orthopedic surgery,
  • able to read and write in Turkish,
  • without any psychiatric illness or reception of psychiatric medications
  • without chronic constipation or reception of constipation medications
  • without abdominal wounds
  • mobilization in the preoperative period
  • without bandages or wraps on the arm and hand that would hinder answering questions
  • ASA score <III,
  • willing to participate in the study.

Exclusion Criteria:

  • patients
  • immobilized for ≥ 2 days postoperatively,
  • with ileus within the first three days postoperatively,
  • discharged or transferred to another service before three days postoperatively,
  • unable to tolerate oral intake due to reasons such as a nasogastric tube or trauma-related jaw and mouth injuries in the postoperative period,
  • who voluntarily withdrew from the study at any stage after volunteering to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Patients in the CG received routine postoperative clinical interventions.
Experimental: Study Group
Patients in the SG received a care package including warm water intake, abdominal massage, and a high-fiber diet.
Other: Warm water intake
Nurses assessed the patients' gag and swallow reflexes in the SG. Patients who experienced nausea after reflex assessment were considered to have positive reflexes and were administered warm water. Packaged water was boiled in a kettle and poured into 200 mL disposable cups. After cooling the water to 38-40°C using a thermometer, patients were instructed to drink it within 3 min.
Other: High-fiber diet
After initiating oral intake, the patients collaborated with a dietitian to incorporate high-fiber foods containing 30 g of fiber daily into their meal menus.
Other: Abdominal massage
Patients in the SG received abdominal massages twice a day, in the morning from 08:00 to 09:00 and in the evening from 19:00 to 20:00, for 15 min per session, starting one day postoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Demographic Characteristics Form:
Time Frame: up to 4 weeks
The first section included questions about the patient's sex, marital status, date of birth, education level, presence of a companion, employment status, presence of chronic diseases, use of continuous medications, type of surgery, general dietary habits, place of residence, bowel habits before surgery, and regular exercise habits. This form was administered to the patients one day before surgery.
up to 4 weeks
Part 2: Constipation Risk Assessment Scale
Time Frame: up to 4 weeks
This scale, developed by Richmond and Wright, has been tested for reliability and validity in Turkish by Koca et al. (2011) [18,19]. The original version of the scale had a Cronbach's alpha value of 0.50; however, it was determined to be 0.43 in the Turkish version [18,19]. Written permission to use the scale was obtained from Koca Kutlu et al. The scale constituted four sections, and scores were assigned at the end of each section. The total score was the sum of the section scores. The score range was 0-63, with higher scores indicating a higher risk of constipation[18]. Individuals scoring ≤10 were classified into the low-risk group, those scoring 11-15 into the moderate-risk group, and those scoring ≥ 16 into the high-risk group. This form was administered to the patients one day before surgery.
up to 4 weeks
Part 3: Visual Analog Scale (VAS):
Time Frame: up to 4 weeks
): The VAS was first used by Pamuk et al. (2003) to determine symptoms related to constipation [20]. Symptoms such as straining, incomplete bowel emptying, constipation, pressure sensation in the rectum, severity of gas formation, and pain in the rectum were measured using the VAS. Low scores indicated mild symptoms, whereas high scores indicated severe symptoms. The VAS was administered to patients one day before surgery (T0) and one (T1), two (T2), three (T3), and four (T4) days postoperatively.
up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kubra KAYA

Investigators

  • Study Director: Kübra KAYA, PhD, kubra.kaya@hku.edu.tr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

February 27, 2023

Study Completion (Actual)

April 3, 2023

Study Registration Dates

First Submitted

April 27, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • kübra_1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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