Investigate the Relationship Between the Psychosocial Factors Affecting Pain Perception and Physical Activity Levels in Pregnant Women With Lumbopelvic PainNCT05418738
The Relationship Between Psychosocial Factors Affecting Pain Perception and Physical Activity Level in Pregnant Women With Lumbopelvic Pain
An observational study of Investigate the Relationship Between the Psychosocial Factors Affecting Pain Perception and Physical Activity Levels in Pregnant Women With Lumbopelvic Pain, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
Lumbopelvic pain (LPP) is a common condition encountered during pregnancy. During pregnancy, 50% of women experience LPP. This study was planned to show the relationship between psychosocial factors affecting the perception of pain such as pregnancy-related psychosocial factors, pregnancy-related distress… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Investigate the Relationship Between the Psychosocial Factors Affecting Pain Perception and Physical Activity Levels in Pregnant Women With Lumbopelvic Pain
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2020to 31 Dec 2020
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women between the ages of 18-45, who had lumbopelvic pain
Who may be able to join
- Women between the ages of 18-45, who had pain in the lumbopelvic region for more than a week, who had pain between 1-10 according to the VAS, who could read and understand Turkish, who were in the second or third trimester of pregnancy, and who did not exercise regularly before pregnancy were included in this cross-sectional and descriptive study.
Who cannot join
- having pregnancy complications (preeclampsia, pregnancy-related hypertension, diabetes, etc.), having gynecological or urological problems leading to pain during pregnancy, and having a history of acute or chronic disease, surgical intervention and trauma in the musculoskeletal or nervous system.
Trial locations and contacts
1 site in 1 country.
About this study
Lumbopelvic pain (LPP) is a common condition encountered during pregnancy. During pregnancy, 50% of women experience LPP. This study was planned to show the relationship between psychosocial factors affecting the perception of pain such as pregnancy-related psychosocial factors, pregnancy-related distress, catastrophization and pain self-efficacy and physical activity level in pregnant women with lumbopelvic pain. This study was conducted using the questionnaires.
Read the detailed description
In pregnant women with lumbopelvic pain, physical activity during pregnancy has many positive effects on both maternal and infant health. Therefore, it is necessary to know the factors affecting physical activity during pregnancy and make arrangements regarding these factors. This study was planned to reveal the relationship between pregnancy-related psychosocial factors, pregnancy-related distress, catastrophizing, and pain self-efficacy, which affect pain perception, and physical activity level in pregnant women with lumbopelvic pain. The study was conducted with 60 pregnant women who met the inclusion criteria. This study was conducted using the questionnaires prepared in the electronic environment and sent to the participants. This study aims to investigate the relationship between the psychosocial factors affecting pain perception and physical activity levels in pregnant women with LPP.
- Keywords
- lumbopelvic pain, psychosocial features, physical activity, pelvic pain, pregnancy
- Medical subject headings
- Motor Activity, Pelvic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
The Antenatal Psychosocial Health Assessment Scale (ALPHA)
ALPHA was used to evaluate the psychosocial states of pregnant women participating in the study. The ALPHA was created by Yıldız in 2011 to assess the psychosocial health states of pregnant women.
Measured: 20 munites
Tilburg Pregnancy Distress Scale (TPDS)
TPDS, was used to determine the distress states of pregnant women. The TPDS is used to assess distress developing during pregnancy. The TPDS, which was created by Pop et al. in 2011, consists of 16 items in total.
Measured: 10 minutes
Pain Catastrophizing Scale (PCS)
PCS, was used to determine ehe level of pain catastrophizing in pregnant women. It was developed by Sullivan et al. in 1995 to assess the exaggerated and negative mental response of individuals during the pain experience, in other words, their levels of catastrophizing. The PCS is comprised of 13 items, including the feelings and opinions of individuals about their last pain experience.
Measured: 10 munites
The Pain Self-Efficacy Questionnaire (PSEQ)
PSEQ applied to the participating pregnant women was created by M.K. Nicholas in 1989 to assess the confidence of individuals, who experienced pain, in carrying out activities despite pain. It consists of 10 items.
Measured: 5 munites
The Pregnancy Physical Activity Questionnaire (PPAQ)
PPAQ was used to reveal the physical activity levels of pregnant women. With this questionnaire, the intensity, frequency, and duration of physical activity are evaluated in pregnant women. It consists of 32 items that assess housework/caregiving activities, professional activities, sports/exercise activities, transportation activities, and inactivity.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Aug 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Investigate the Relationship Between the Psychosocial Factors Affecting Pain Perception and Physical Activity Levels in Pregnant Women With Lumbopelvic PainStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tuba kolaylı, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418738
- Sponsor's protocol ID
- Uskudar University
- Status last verified
- Jun 2022
- First submitted
- 9 Jun 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Psychosocial Factors Affecting Pain Perception and Physical Activity Level in Pregnant Women With Lumbopelvic Pain
- ClinicalTrials.gov ID
- NCT05418738
- Acronym / sponsor ID
- Uskudar University
- Keywords
- lumbopelvic pain, psychosocial features, physical activity, pelvic pain, pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 14 Jun 2022 (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.
Lumbopelvic pain (LPP) is a common condition encountered during pregnancy. During pregnancy, 50% of women experience LPP. This study was planned to show the relationship between psychosocial factors affecting the perception of pain such as pregnancy-related psychosocial factors, pregnancy-related distress, catastrophization and pain self-efficacy and physical activity level in pregnant women with lumbopelvic pain. This study was conducted using the questionnaires.
Detailed description
In pregnant women with lumbopelvic pain, physical activity during pregnancy has many positive effects on both maternal and infant health. Therefore, it is necessary to know the factors affecting physical activity during pregnancy and make arrangements regarding these factors. This study was planned to reveal the relationship between pregnancy-related psychosocial factors, pregnancy-related distress, catastrophizing, and pain self-efficacy, which affect pain perception, and physical activity level in pregnant women with lumbopelvic pain. The study was conducted with 60 pregnant women who met the inclusion criteria. This study was conducted using the questionnaires prepared in the electronic environment and sent to the participants. This study aims to investigate the relationship between the psychosocial factors affecting pain perception and physical activity levels in pregnant women with LPP.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women between the ages of 18-45, who had lumbopelvic pain
Key inclusion criteria (1 listed)
- Women between the ages of 18-45, who had pain in the lumbopelvic region for more than a week, who had pain between 1-10 according to the VAS, who could read and understand Turkish, who were in the second or third trimester of pregnancy, and who did not exercise regularly before pregnancy were included in this cross-sectional and descriptive study.
Key exclusion criteria (1 listed)
- having pregnancy complications (preeclampsia, pregnancy-related hypertension, diabetes, etc.), having gynecological or urological problems leading to pain during pregnancy, and having a history of acute or chronic disease, surgical intervention and trauma in the musculoskeletal or nervous system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Antenatal Psychosocial Health Assessment Scale (ALPHA)
Time frame: 20 munites
ALPHA was used to evaluate the psychosocial states of pregnant women participating in the study. The ALPHA was created by Yıldız in 2011 to assess the psychosocial health states of pregnant women.
Tilburg Pregnancy Distress Scale (TPDS)
Time frame: 10 minutes
TPDS, was used to determine the distress states of pregnant women. The TPDS is used to assess distress developing during pregnancy. The TPDS, which was created by Pop et al. in 2011, consists of 16 items in total.
Pain Catastrophizing Scale (PCS)
Time frame: 10 munites
PCS, was used to determine ehe level of pain catastrophizing in pregnant women. It was developed by Sullivan et al. in 1995 to assess the exaggerated and negative mental response of individuals during the pain experience, in other words, their levels of catastrophizing. The PCS is comprised of 13 items, including the feelings and opinions of individuals about their last pain experience.
The Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: 5 munites
PSEQ applied to the participating pregnant women was created by M.K. Nicholas in 1989 to assess the confidence of individuals, who experienced pain, in carrying out activities despite pain. It consists of 10 items.
The Pregnancy Physical Activity Questionnaire (PPAQ)
Time frame: 20 minutes
PPAQ was used to reveal the physical activity levels of pregnant women. With this questionnaire, the intensity, frequency, and duration of physical activity are evaluated in pregnant women. It consists of 32 items that assess housework/caregiving activities, professional activities, sports/exercise activities, transportation activities, and inactivity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Investigate the Relationship Between the Psychosocial Factors Affecting Pain Perception and Physical Activity Levels in Pregnant Women With Lumbopelvic Pain, run by Uskudar 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 1 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: finished, as of the sponsor's last update on 14 Jun 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Antenatal Psychosocial Health Assessment Scale (ALPHA) (time frame: 20 munites). The study lists 5 primary outcomes in all. 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 14 Jun 2022.