Care Package for Postoperative Constipation

NCT06399133 | Completed DMC

• 1 other identifier: kübra_1
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Care; Constipation

Keywords

Constipation Risk; Constipation Severity; Nursing; Care; Constipation

Outcome Measures

Primary Outcomes (3)

• Part 1: Demographic Characteristics Form:

  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

  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):

  ): 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

Study Arms (2)

Control Group

NO INTERVENTION

Patients in the CG received routine postoperative clinical interventions.

Study Group

EXPERIMENTAL

Patients in the SG received a care package including warm water intake, abdominal massage, and a high-fiber diet.

Other: Warm water intake; Other: High-fiber diet; Other: Abdominal massage

Interventions

Warm water intake OTHER

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.

Study Group

High-fiber diet OTHER

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.

Study Group

Abdominal massage OTHER

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.

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kubra KAYA: lead

Study Sites (1)

Orthopedics and Traumatology Clinic of Abdulkadir Yüksel State Hospital in Gaziantep.

Gaziantep, Central, 27100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kübra KAYA, PhD

  kubra.kaya@hku.edu.tr

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 Record Dates

• First Submitted: April 27, 2024
• First Posted: May 3, 2024
• Study Start: January 1, 2023
• Primary Completion: February 27, 2023
• Study Completion: April 3, 2023
• Last Updated: May 3, 2024

Record last verified: 2024-04

Locations

TU (1)