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CompletedNCT06399133Car_PackageUpdated May 3, 2024

Care Package for Postoperative Constipation

An interventional study of Warm water intake and High-fiber diet in Care and Constipation, sponsored by Kubra KAYA. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-03.

Sponsored by Kubra KAYA · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jan 2023, registered Apr 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Care
  • Constipation

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Keywords

  • Constipation Risk
  • Constipation Severity
  • Nursing
  • Care
  • Constipation
03

In context

Constipation

1,041 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's enrollment of 102 is above the median of 78 across 867 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

This is the only study on the registry with Kubra KAYA as lead sponsor.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  • 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • 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 · Other: High-fiber diet · Other: Abdominal massage

Interventions

  • OtherWarm 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.

  • OtherHigh-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.

  • OtherAbdominal 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 4 weeks

  2. 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.

    Time frame: up to 4 weeks

  3. 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.

    Time frame: up to 4 weeks

07

Study locations

1 site
  • Orthopedics and Traumatology Clinic of Abdulkadir Yüksel State Hospital in Gaziantep.
    Gaziantep, Central 27100, Turkey (Türkiye)
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2023 to primary completion in Feb 2023, 1 month.

Of 229 non-industry interventional studies with no phase under Constipation, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 35. This study's 1 month is below that.

Counting every sponsor, half of 296 studies reached it within 14 months; a quarter within 7 and three quarters within 28.

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

Registered
Apr 27, 2024
First posted
May 3, 2024
StartActual
Jan 1, 2023
Primary completionActual
Feb 27, 2023
CompletionActual
Apr 3, 2023
Last update
May 3, 2024
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 May 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06399133
Lead sponsor
Kubra KAYA
Responsible party
Kubra KAYA (Principal Investigator, Hasan Kalyoncu University) — Sponsor-investigator
First posted
May 3, 2024
Start date
Jan 1, 2023
Primary completion
Feb 27, 2023
Completion
Apr 3, 2023
Last update
May 3, 2024

Study contacts

Kübra KAYA, PhD
study director · kubra.kaya@hku.edu.tr

Oversight

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

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