Postmenopausal SymptomsNCT03640962
Relationship in Sleep With Low Back Pain in Postmenopausal Period
An observational study of Postmenopausal Symptoms, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Symptoms
- What is being tested?
- Evaluation
- How many people
- 368 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Apr 2018to 22 Sep 2018
- How long will I take part?
- 5 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Postmenopausal women aged between 40 and 65 years. This study was carried out in family health centers in Istanbul.
Who may be able to join
- Participants who have not had menstrual bleeding for the last 1 year
- FSH levels above 30 mlU / ml
Who cannot join
- illiterate women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Relationship in Sleep With Low Back Pain in Postmenopausal Period
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.
Read the detailed 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.
- Conditions
- Postmenopausal Symptoms
- Being tested
- Evaluation
- Keywords
- Postmenopause, Low back pain, Woman
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvaluationOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 minute
Secondary outcomes (3)
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
Measured: 5 minutes
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)
Measured: 5 minutes
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 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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start2 Apr 2018
- Primary completion25 Jun 2018
- Study completion22 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 368 participants (actual)
- Target duration
- 5 Months
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TOMRIS DUYMAZ, Istanbul Bilgi University
- Investigators
- TOMRIS DUYMAZ, Principal investigator, Istanbul Bilgi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640962
- Sponsor's protocol ID
- IBU17.02.2015/28-210
- Status last verified
- Sep 2018
- First submitted
- 17 Aug 2018
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship in Sleep With Low Back Pain in Postmenopausal Period
- ClinicalTrials.gov ID
- NCT03640962
- Acronym / sponsor ID
- IBU17.02.2015/28-210
- Conditions
- Postmenopausal Symptoms
- Keywords
- Postmenopause, Low back pain, Woman
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 25 Jun 2018 (actual)
- Study completion
- 22 Sep 2018 (estimated)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Months
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women aged between 40 and 65 years. This study was carried out in family health centers in Istanbul.
Key inclusion criteria (2 listed)
- Participants who have not had menstrual bleeding for the last 1 year
- FSH levels above 30 mlU / ml
Key exclusion criteria (1 listed)
- illiterate women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvaluationThis 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. | Other | – |
Primary outcome
Pain of low back pain: Visual Analog Scale
Time frame: 1 minute
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)
3 secondary outcomes
Emotional status: Hospital Anxiety and Depression Scale
Time frame: 5 minutes
Quality of life of women: Nottingham Health Profile
Time frame: 5 minutes
Sleep quality: Pittsburgh Sleep Quality Index
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TOMRIS DUYMAZ principal investigator
Istanbul Bilgi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopausal Symptoms, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain of low back pain: Visual Analog Scale (time frame: 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.