Relationship in Sleep With Low Back Pain in Postmenopausal Period

Postmenopausal Symptoms Clinical Trial

Official title:

Investigation of the Relationship in Sleep With Low Back Pain in Postmenopausal Period

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03640962
• Other study ID #: IBU17.02.2015/28-210
• Status: Active, not recruiting
• Start date: April 2, 2018
• Est. completion date: September 22, 2018

Study information

• Verified date: September 2018
• Source: Istanbul Bilgi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Participants 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. Participants who have not had menstrual bleeding for the last 1 year and, with FSH levels above 30 mlU / ml were included in this study. My exclusion criteria in the study were illiterate women. All participants were given informed consent about the aim and methods of the study.

Study design Data were collected via face-to-face interviews by the researcher. Socio-demographic data ascertained included age, Body Mass Index (BMI), marital status, tobacco and alcohol use, medication use, presence of chronic disease, age of menopause onset, and educational level. All participants were recorded frequency and severity of low back pain, depressive symptoms, anxiety, quality of life and sleep quality. Outcome measures are described in more detail below. According to the power analysis results, when the number of enough participants was reached, the study was stopped. Ethics committee approval for the study was obtained from the Istanbul Science University Ethics Committee for Clinical Researches (IBU17.02.2015/28-210).

Outcome measurements Pain 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).

Emotional Status Hospital Anxiety and Depression Scale (HADS) was used to determine the level of anxiety and depression of the participants. It contains 14 items, seven related to depression and seven to anxiety. Each item is rated in a 4 point scale. A subscale score of 0-21 and to a total score of 0-42. Scores of 11 or more on either sub-scale is considered to be a significant "case" of psychological morbidity, while scores of 8 to 10 represent "borderline" and 0 to 7 "normal". It was originally developed in 1983 by Zigmond and Snaith in order to evaluate the risk for anxiety and depression in patient and to measure the level and severity of anxiety/ depression. The validity and reliability of Turkish version of the HAD Scale was tested in 1997 by Aydemir.

Quality of Life Nottingham Health Profile (NHP) was used to determine quality of life of the participants. NHP is a general health status scale (health-related quality of life), which aims to measure a patient's perceived emotional, social and physical health status. This scale consists of 38 items formed as yes-no questions that cover 6 subscales of the quality of life. These six subscales are sleep (5 item), energy level (3 item), emotional status (9 item), social isolation (5 item), physical mobility (8 item) and pain (8 item). Each section is scored from 0-100. 0 indicates the best health status, 100 indicates the worst health status. In the study, the sub-scores of NHP and total NHP scores were evaluated. Total NHP score was obtained from the sum of the sub-scores. The scale was developed by Hunt et al.(1981). NHP is an easy-to-use scale and the validity and reliability of Turkish version was by Küçükdeveci at al.(2000).

Sleep Quality Pittsburgh Sleep Quality Index (PSQI) was used to determine sleep quality of the participants. PSQI was originally developed by Buysse et al.(1989). PSQI was adapted into Turkish by Ağargün et al.(1996). PSQI is consisting of 24 items, 19 of which are self-assessment questions and the rest 5 are answered by patient's spouse or roommate. The scored 18 items covers 7 components, namely subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorders, use of sleeping medication and daytime dysfunction. Each component is evaluated on a 0-3 interval scale whereby 3 reflect the negative extreme on the Likert Scale. The total score obtained from the seven components are equivalent to the total scale score. The total score ranges between 0 and 21; higher scores indicate worse sleep quality.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 368
• Est. completion date: September 22, 2018
• Est. primary completion date: June 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participants who have not had menstrual bleeding for the last 1 year

• FSH levels above 30 mlU / ml

Exclusion Criteria:

• illiterate women

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Postmenopausal Symptoms

Intervention

Other:
• Evaluation
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.

Locations

Country	Name	City	State
Turkey	Tomris Duymaz	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Bilgi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Emotional status: Hospital Anxiety and Depression Scale	Hospital Anxiety and Depression Scale (HADS) was used to determine the level of anxiety and depression of the participants. It contains 14 items, seven related to depression and seven to anxiety. Each item is rated in a 4 point scale. A subscale score of 0-21 and to a total score of 0-42. Scores of 11 or more on either sub-scale is considered to be a significant "case" of psychological morbidity, while scores of 8 to 10 represent "borderline" and 0 to 7 "normal". It was originally developed in 1983 by Zigmond and Snaith in order to evaluate the risk for anxiety and depression in patient and to measure the level and severity of anxiety/ depression. The validity and reliability of Turkish version of the HAD Scale was tested in 1997 by Aydemir	5 minutes
Secondary	Quality of life of women: Nottingham Health Profile	Nottingham Health Profile (NHP) was used to determine quality of life of the participants. NHP is a general health status scale (health-related quality of life), which aims to measure a patient's perceived emotional, social and physical health status. This scale consists of 38 items formed as yes-no questions that cover 6 subscales of the quality of life. These six subscales are sleep (5 item), energy level (3 item), emotional status (9 item), social isolation (5 item), physical mobility (8 item) and pain (8 item). Each section is scored from 0-100. 0 indicates the best health status, 100 indicates the worst health status. In the study, the sub-scores of NHP and total NHP scores were evaluated. Total NHP score was obtained from the sum of the sub-scores. The scale was developed by Hunt et al.(1981). NHP is an easy-to-use scale and the validity and reliability of Turkish version was by Küçükdeveci at al.(2000)	5 minutes
Secondary	Sleep quality: Pittsburgh Sleep Quality Index	Pittsburgh Sleep Quality Index (PSQI) was used to determine sleep quality of the participants. PSQI was originally developed by Buysse et al.(1989). PSQI was adapted into Turkish by Agargün et al.(1996). PSQI is consisting of 24 items, 19 of which are self-assessment questions and the rest 5 are answered by patient's spouse or roommate. The scored 18 items covers 7 components, namely subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorders, use of sleeping medication and daytime dysfunction. Each component is evaluated on a 0-3 interval scale whereby 3 reflect the negative extreme on the Likert Scale. The total score obtained from the seven components are equivalent to the total scale score. The total score ranges between 0 and 21; higher scores indicate worse sleep quality.	5 minutes