Relationship in Sleep With Low Back Pain in Postmenopausal Period

NCT03640962 | Unknown DMC

• 1 other identifier: IBU17.02.2015/28-210
• Study Type: observational
• Target: 368
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction:The aim of this study was to investigate the incidence of low back pain in postmenopausal period and the relationship between low back pain and emotional state,sleep and quality of life i aimed at investigating low back pain during postmenopausal period of women and its correlation with the emotional state,sleep quality and the quality of life of woman. Method:This cross-sectional study was conducted in 368 postmenopausal women aged between 40 and 65 years.All participants were recorded frequency and severity of low back pain,depressive symptoms and anxiety,quality of life and sleep quality.Outcome measures are described in more detail below.

Conditions

Postmenopausal Symptoms

Keywords

Postmenopause; Low back pain; Woman

Outcome Measures

Primary Outcomes (1)

• Pain of low back pain: Visual Analog Scale

  Visual Analog Scale: To determine the frequency of current pain, all eligible participants were evaluated and asked to report whether they had had pain. All participants were evaluated for severity of pain using an 11-point numeric visual analog scale (VAS; 0= no pain; 10=worst pain imaginable). Participants were asked to characterize their pain severity along a horizontal, 10-cm line. Participants were questioned about the severity of low back pain during rest, during activity and at night. Statistics were made by categorizing the severity of low back pain during rest, activityand at night. Low back pain intensity were classified that according to the cut-off point of the VAS. (0.1-3.8 mild pain, 3.9-5.7 moderate pain, 5.8-10 severe pain)

  1 minute

Secondary Outcomes (3)

• Emotional status: Hospital Anxiety and Depression Scale

  5 minutes

• Quality of life of women: Nottingham Health Profile

  5 minutes

• Sleep quality: Pittsburgh Sleep Quality Index

  5 minutes

Interventions

Evaluation OTHER

This cross-sectional study was conducted in 368 postmenopausal women aged between 40 and 65 years. This study was carried out in family health centers in Istanbul. Data were collected via face-to-face interviews by the researchers.

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: Postmenopausal women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Postmenopausal women aged between 40 and 65 years. This study was carried out in family health centers in Istanbul.

You may qualify if:

• Participants who have not had menstrual bleeding for the last 1 year
• FSH levels above 30 mlU / ml

You may not qualify if:

• illiterate women

Sponsors & Collaborators

• Istanbul Bilgi University: lead

Study Sites (1)

Tomris Duymaz

Istanbul, 34440, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• TOMRIS DUYMAZ

  Istanbul Bilgi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Ph.D.

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 21, 2018
• Study Start: April 2, 2018
• Primary Completion: June 25, 2018
• Study Completion: September 22, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

TU (1)