NCT05287789

Brief Summary

One of the most common nursing care problems after surgery is defecation problems and the risk of constipation. The aim of the study was to determine the effectiveness of the squatting position with footstool on the constipation severity and defecation problems in the postoperative period in patients with hernia surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2021

Completed
1 year until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

March 18, 2021

Last Update Submit

March 10, 2022

Conditions

Keywords

Squatting PositionConstipationDefecation problemsClinical Nursing Research

Outcome Measures

Primary Outcomes (1)

  • Change from before surgery in The Constipation Severity Scale (CSS) average score

    Constipation Severity Scale (CSS) aims to determine individuals' defecation frequency, intensity, and difficulty. The CSS consists of 16 items and three sub dimensions, namely Excrement Congestion, Large Bowel Laziness, and Pain. The lowest score that can be attained from the CSS is 0 while the highest score that can be attained is 73.

    Data were collected before surgery, post-op 1st day, post-op 2nd day and on the 7th day after discharge. All of the patients were discharged on the 2nd postoperative day.

Secondary Outcomes (5)

  • Difficulty pushing in defecation average score

    Data were collected post-op 2nd day and on the 7th day after discharge. All of the patients were discharged on the 2nd postoperative day.

  • Duration of defecation, average minutes

    Data were collected post-op 2nd day and on the 7th day after discharge. All of the patients were discharged on the 2nd postoperative day.

  • Defecation pain average score

    Data were collected post-op 2nd day and on the 7th day after discharge. All of the patients were discharged on the 2nd postoperative day.

  • Stool consistency

    Data were collected post-op 2nd day and on the 7th day after discharge. All of the patients were discharged on the 2nd postoperative day.

  • Fear of pushing in defecation average score

    Data were collected post-op 2nd day and on the 7th day after discharge. All of the patients were discharged on the 2nd postoperative day.

Study Arms (2)

Squatting position by footstool

EXPERIMENTAL

After the first postoperative ambulation, stable patients whose bowel movements resumed met their initial defecation needs with the squatting position created using a footstool at the appropriate height on the water closet type toilet. The patients used footstools in the hospital and throughout a week after discharge at home for defecation.

Other: Squatting position by footstool

Control Group

NO INTERVENTION

The control group received the routine care provided to all the patients in the clinic with no additional interventions.

Interventions

Before the study, the height of the toilet bowls in the patient rooms was measured as 42 cm. The stools to be used for the study are manufactured by ordering laminated with white medium density fiberboard and synthetic resin resistant to harsh chemicals. Stools are made of high quality non-slip materials for patient safety. After the first postoperative ambulation, stable patients whose bowel movements resumed met their initial defecation needs with the squatting position created using a stool at the appropriate height on the water closet type toilet. The patients used footstools throughout a week after discharge at home and in the hospital for defecation.

Squatting position by footstool

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hernia surgery in the general surgery clinic
  • Between 18 and 65 years of age
  • BMI between normal and overweight (18.50-24,99 kg/m2: Normal,25-29,99 kg/m2: Overweight)
  • Being able to establish verbal communication
  • Volunteering to participate in the study
  • Absence of mental confusion
  • Having full consciousness and orientation
  • Having no communication difficulties
  • Having a constipation risk between moderate to high
  • Using a water closet type toilet at home

You may not qualify if:

  • Having a low risk of constipation
  • Patient who declined to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk University

Karabük, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Meltem Kaya

    Karabuk University

    PRINCIPAL INVESTIGATOR
  • Aysegul Oksay Sahin

    Karabuk University

    STUDY CHAIR
  • Isıl Isık Andsoy

    Karabuk University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: pretest-posttest time series model with the different control group
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer, MSc

Study Record Dates

First Submitted

March 18, 2021

First Posted

March 18, 2022

Study Start

January 1, 2018

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

March 18, 2022

Record last verified: 2022-03

Locations