Low Back Pain Support Program During Pregnancy: A Randomized Controlled Trial

NCT ID: NCT05684497

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-09
• Study Completion Date: 2022-12-30

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.

Detailed Description

The research population consisted of all pregnant women registered at a Family Health Center between July 2021 and July 2022.The power of the study was calculated in the G*Power (v3.1.9.4) program to determine the number of samples. Oswestry Disability Index was taken as the main parameter in the study. In the survey conducted by Pekcetin et al., the Oswestry Disability Index scale score average of the group to be trained was found to be 39.53 ±14.04 before the training and 26.96 ±13.69 after the training (Pekcetin et al., 2019). In the statistical analysis performed by taking the results of this study as a criterion, the alpha reliability level of the survey was taken as 0.01. The power was 80%, and according to the Oswestry Disability Index scale, the score was average. It was determined that 36 pregnant women should be included in the group. However, considering the possibility of data loss, a total of 80 pregnant women, 40 were included in the group that would be included in the low back pain prevention and coping support program in addition to routine pregnant care, and 40 were included in the group that would receive only routine antenatal care.

The allocation of intervention and control groups was determined using the simple random sampling method (random.org). The numbers determined by the simple random sampling method became the appointment order.

Criteria for inclusion in the study;

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

Exclusion criteria from the study:

• 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. After the researcher called the pregnant women via phone and evaluated their compliance with the research criteria, the pregnant women who met the inclusion criteria were informed about the research and invited to the study. Data were collected by face-to-face interviews with all pregnant women in the study in an isolated room.

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.

The purpose and content of LBPSP was explained and contucted to the intervention group. LBPSP is a 50-minute interactive presentation as face to face program according to Pender's Health Promotion Model Parameters. LBPSP content is given in Figure 3. And also, a special LBPSP handbook has been prepared for this program, enriched with visuals for pregnant women and printed. This handbook was given to the intervention group after LBPSP.

Conditions

Low Back Pain; Pregnancy Related; Nurse's Role

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

experimental group

The intervention group was conducted a LBPSP

Group Type: EXPERIMENTAL

LBPSP in Pregnancy

Intervention Type: BEHAVIORAL

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

control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

LBPSP in Pregnancy

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kastamonu University

OTHER

Sponsor Role: lead

Responsible Party

Munevver Aybuke Berber Cikrik

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Münevver Aybüke Berber Çıkrık

Role: STUDY_DIRECTOR

Istanbul University Cerrahpasa Institute of Graduate Education Studies

Münevver Aybüke Berber Çıkrık

Role: STUDY_DIRECTOR

stanbul University Cerrahpasa Institute of Graduate Education Studies

Locations

Münevver Aybüke Berber Çıkrık

Kastamonu, Kastamonu/Center, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Kastamonu University

Identifier Type: -

Identifier Source: org_study_id