NCT05684497

Brief Summary

Purpose of Research: The study was conducted as a randomized controlled experimental study to evaluate the effect of the Low Back Pain During Pregnancy Support Program (LBPSP). Research Hypotheses H1: The perception of back pain during pregnancy in the intervention group receiving the "Low Back Pain During Pregnancy Support Program (LBPSP) will decrease compared to the control group. H2: The Oswestry Disability Index scores of the intervention group receiving the Low Back Pain During Pregnancy Support Program (LBPSP) will decrease compared to the control group. First interview Introductory Information Form, Low Back Pain Evaluation Form, Visual Analog Scale (VAS), and Oswestry Disability Index were applied to all pregnant women in the intervention and control groups participating in the study as pre-test at the first interview. The intervention group was conducted a LBPSP, the control group were not and were left to routine antenatal care.Four weeks after the first interview, Intervention and control groups were interviewed again, and the Low Back Pain Evaluation Form and Oswestry Disability Index scales were applied. In addition, the LBPSP Evaluation Form prepared by the researcher was applied to the pregnant women in the intervention group to evaluate the LBPSP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable low-back-pain

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

July 9, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

1.1 years

First QC Date

January 16, 2022

Last Update Submit

November 20, 2024

Conditions

Low Back PainPregnancy RelatedNurse's Role

Keywords

Back Pain; Life Quality; Nursing; Pregnancy, Pender's Health Promotion Model

Outcome Measures

Primary Outcomes (2)

  • pregnancy related low back pain

    measurement of low back pain life status of pregnant women with VAS

    each participant will be re-evaluated at the end of 4 weeks

  • quality of life in pregnancy

    measurement of pregnant women's quality of life with Oswestry disability index

    each participant will be re-evaluated at the end of 4 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

The intervention group was conducted a LBPSP

Behavioral: LBPSP in Pregnancy

control group

NO INTERVENTION

the control group were not and were left to routine antenatal care.

Interventions

LBPSP in PregnancyBEHAVIORAL

LBPSP is a 50-minute interactive presentation as face to face program according to Pender's Health Promotion Model Parameters.

experimental group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Read and write in Turkish,
  • years and over aged,
  • Three or more score low back pain according to VAS
  • Singleton pregnancy

You may not qualify if:

  • Gynecological or urological problems that cause pain during pregnancy (premature birth, pyelonephritis, etc.)
  • Using analgesics during pregnancy,
  • Risky pregnancies for which bed rest is recommended during pregnancy,
  • Were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Münevver Aybüke Berber Çıkrık

Kastamonu, Kastamonu/Center, 37000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back PainBack Pain

Interventions

Pregnancy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Münevver Aybüke Berber Çıkrık

    Istanbul University Cerrahpasa Institute of Graduate Education Studies

    STUDY DIRECTOR

  • Münevver Aybüke Berber Çıkrık

    stanbul University Cerrahpasa Institute of Graduate Education Studies

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 16, 2022

First Posted

January 13, 2023

Study Start

July 9, 2021

Primary Completion

July 30, 2022

Study Completion

December 30, 2022

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)