Clinical trial NCT06399133: Care Package for Postoperative Constipation
Official title: Care Package for Postoperative Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Care
Constipation
Keywords: Constipation Risk
Constipation Severity
Nursing
Care
Constipation
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Part 1: Demographic Characteristics Form:
timeFrame: up to 4 weeks
measure: Part 2: Constipation Risk Assessment Scale
timeFrame: up to 4 weeks
measure: Part 3: Visual Analog Scale (VAS):
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Orthopedics and Traumatology Clinic of Abdulkadir Yüksel State Hospital in Gaziantep.
state: Central
Study officials:
affiliation: kubra.kaya@hku.edu.tr
name: Kübra KAYA, PhD
role: STUDY_DIRECTOR
References: