Assess the Quality of Life of Pregnant Women With FibromyalgiaNCT07821892
Effect of Community-Based Nursing Interventions on Quality of Life in Pregnant Women With Fibromyalgia
A study testing community based nursing interventions and routine care in people with Assess the Quality of Life of Pregnant Women With Fibromyalgia, run by farha Ali El-refaie Abdelhamed at 1 site in Egypt.
Trial summary
Fibromyalgia is a long-term, complex disorder marked by widespread pain in the muscles and joints, ongoing fatigue, sleep disturbances, mood changes, and cognitive difficulties, all of which can significantly disrupt daily activities and reduce overall quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Assess the Quality of Life of Pregnant Women With Fibromyalgia
- What is being tested?
- community based nursing interventions and routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2025to 30 Aug 2026
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pregnant women diagnosed with fibromyalgia in 1st or 2nd trimester.
- Age ≥18 years
Who cannot join
- those suffering from severe cognitive or mental disorder
- Having major obstetric complications
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kafr el-sheikh University Hospital
Kafr ash Shaykh, Kafr el-Sheikh Governorate
About this study
Official title: Effect of Community-Based Nursing Interventions on Quality of Life in Pregnant Women With Fibromyalgia: A Randomized Controlled Trial
Fibromyalgia is a long-term, complex disorder marked by widespread pain in the muscles and joints, ongoing fatigue, sleep disturbances, mood changes, and cognitive difficulties, all of which can significantly disrupt daily activities and reduce overall quality of life. Women with fibromyalgia who become pregnant often encounter increased challenges, as the physical, emotional, and social demands of pregnancy can exacerbate their symptoms. This combination frequently results in heightened pain, more severe fatigue, greater sleep disturbances, increased anxiety, and a decline in overall psychological well-being, potentially leading to negative outcomes for both the mother and baby . Pregnancy brings a distinct set of difficulties for women with fibromyalgia, as bodily changes, hormonal shifts, and heightened physical requirements may worsen symptoms like generalized pain, tiredness, and sleep problems . These complications can influence the health of both the expectant mother and her baby. Providing nursing care in such cases calls for advanced expertise to effectively manage these complexities and uphold the well-being of both mother and fetus .
Read the detailed description
Despite increased awareness of the challenges that fibromyalgia presents during pregnancy, evidence-based guidelines for optimal management remain limited, and the use of medications is often restricted due to concerns about fetal safety .Consequently, there is a growing emphasis on non-pharmacological and holistic approaches particularly those delivered by nurses in community settings for their potential to alleviate symptoms and enhance the quality of life for pregnant women with fibromyalgia .
Community-based nursing approaches offer an effective structure for individualized care, focusing on educating pregnant women about managing their symptoms, lowering stress, and making lifestyle adjustments suited to pregnancy . Customized support throughout pregnancy can help control symptoms, lessen anxiety, and contribute to better health outcomes for women with fibromyalgia Also, It offered within the community centering on patient education, strategies for self-management, physical activity and emotional support are designed to be accessible, cost-effective, and responsive to the particular needs of pregnant women . When such interventions are multidisciplinary, incorporating elements like exercise, pain education, nutrition, peer encouragement, and cognitive-behavioral techniques, they have shown to improve patients' satisfaction with care, boost daily functioning, enhance psychological health, and promote healthier coping mechanisms for chronic illnesses like fibromyalgia .
Quality of life (QoL) refers to a broad concept involving physical health, mental wellbeing, and social functioning. For pregnant women with chronic conditions such as fibromyalgia, persistent pain, exhaustion, and psychological stress can greatly diminish QoL. One of the main objectives of nursing interventions is to improve QoL by not just reducing symptoms, but also promoting better daily functioning and emotional strength. Regular assessment of QoL helps nurses tailor care strategies that adapt to the patient's ongoing feedback and changing circumstances.
Nursing professionals play a crucial role in delivering community-based interventions that enhance the quality of life for pregnant women affected by fibromyalgia. Community-based nursing care offers patient-focused, easily accessible strategies customized to meet the specific needs of individuals. This care model integrates health education, promotes self-management skills, encourages physical activity, and provides psychosocial support to enhance overall health outcomes. Nurses facilitate crucial components in managing the specific challenges faced by pregnant women with fibromyalgia through the incorporation of exercise regimens, dietary guidance, and cognitive-behavioral therapy. These nurse-led multidisciplinary interventions have been shown to significantly enhance patients' physical functioning, mood stability, and their overall satisfaction with the care received. By targeting both physical symptoms and psychological well-being, these comprehensive approaches contribute to better health outcomes and improve the overall care experience for this population.
Nursing interventions also promote peer support and active patient involvement, assisting individuals in developing healthier beliefs about pain and strengthening their coping skills. Research shows that community-based care models not only improve daily functioning and mental health but also boost patient satisfaction by addressing the physical, emotional, and social aspects that collectively affect quality of life . Thus , Community-based nursing interventions offer an all-encompassing framework that supports the overall well-being of pregnant women with fibromyalgia. These interventions are integral to multidisciplinary and holistic care models .
Significance of the study:
Fibromyalgia is a prevalent global health issue, affecting approximately 2% to 5% of the population worldwide, with a markedly higher incidence in women, accounting for 80% to 90% of cases . In Egypt, while general data on fibromyalgia prevalence is still developing, specific populations such as university students have shown a prevalence rate as high as 12.4%. When applied to pregnant women, fibromyalgia poses increased challenges due to physiological and hormonal changes during gestation that may exacerbate symptoms . Studies indicate that fibromyalgia is relatively common in pregnant women, with some research reporting prevalence rates up to 37.7%. This higher prevalence underscores the need for targeted nursing interventions and specialized care plans to manage the intensified symptoms and promote better maternal and fetal health outcomes.
This research broadens the understanding of nursing's critical role in managing chronic pain, particularly highlighting how community-based nursing interventions can improve outcomes for pregnant women with fibromyalgia. Such initiatives have the potential to enhance quality of life by addressing key symptoms like pain while also reducing healthcare costs and elevating care standards through personalized, accessible support. The objective of this research is to examine the impact of community-based nursing intervention on the quality of life, symptom management, and overall well-being of this unique population, emphasizing the effectiveness and importance of holistic nursing care approaches in chronic condition management during pregnancy.
- Being tested
- community based nursing interventions, routine care
- Keywords
- quality of life, fibromyalgia, pregnant women, Randomized controlled Trials
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
community based nursing interventionsBehavioural
The intervention groups were made up of ten individuals per cohort for a total of Five cohorts. Each cohort Participant flow through the study participated in a 8-week intervention which included once weekly education sessions at Kafr-elshiekh university hospital and twice-weekly exercise sessions. During the first exercise session, participants underwent a one-on-one baseline assessment and were given an individualized exercise program to follow during the twice-weekly exercise sessions. exercise sessions including prenatal yoga, stretching, and aquatic exercises where feasible Tailored intensity based on individual tolerance and obstetric safety guidelines. In relation to education sessions, its component was developed based on evidence-based practice guidelines for fibro myalgia and chronic pain self-management. The 1-hour sessions took place weekly, immediately following one of the exercise sessions.
routine careOther
usual care for fibromyalgia involves a referral to a rheumatologist. Therefore, patients assigned to the control group were referred to a local rheumatologist for a single, one hour, one-on-one consultation. During this appointment, the patient's history was taken, a physical exam was performed, basic education about fibromyalgia was provided, At the conclusion of the study (i.e., two-month follow-up questionnaires were collected from all participants).
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The intervention groups were made up of ten individuals per cohort for a total of Five cohorts. Each cohort Participant flow through the study participated in a 8-week intervention which included once weekly education sessions at Kafr-elshiekh university hospital and twice-weekly exercise sessions. Receives: Behavioral: community based nursing interventions |
| control group | Active comparator | The control groups were made up of ten individuals per cohort for a total of three cohorts running simultaneously with each intervention group. Participants randomized to the control group received usual care. Receives: Other: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Quality of Life
is 14-item Quality of Life scale that is specific and validated to patients with fibromyalgia
Measured: 1-Baseline Assessment ( T_0- Week 0): Administered immediately after study enrollment and random allocation 2-Mid-Intervention Assessment (T_1 - End of Week 4 / Day 28±3 days) 3-Post-Intervention Follow-Up Assessment (T_2 - End of Week 8 / Day 56±3 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start10 Oct 2025
- Primary completion30 Jul 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assess the Quality of Life of Pregnant Women With FibromyalgiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- farha Ali El-refaie Abdelhamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, farha Ali El-refaie Abdelhamed, Kafrelsheikh University
- Investigators
- Farha A El-refaie, PhD, Principal investigator, faculty of nursing Kafrelsheikh university, EgyptAmany L Ahmed, PhD, Study chair, faculty of nursing Kafrelsheikh university, EgyptRabab S Hassan, Study director, faculty of nursing Cairo university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821892
- Sponsor's protocol ID
- KFSIRB200-737
- Status last verified
- Sep 2026
- First submitted
- 11 Jul 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Community-Based Nursing Interventions on Quality of Life in Pregnant Women With Fibromyalgia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07821892
- Acronym / sponsor ID
- KFSIRB200-737
- Keywords
- quality of life, fibromyalgia, pregnant women, Randomized controlled Trials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- farha Ali El-refaie AbdelhamedUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 16 Sep 2026 (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.
Fibromyalgia is a long-term, complex disorder marked by widespread pain in the muscles and joints, ongoing fatigue, sleep disturbances, mood changes, and cognitive difficulties, all of which can significantly disrupt daily activities and reduce overall quality of life. Women with fibromyalgia who become pregnant often encounter increased challenges, as the physical, emotional, and social demands of pregnancy can exacerbate their symptoms. This combination frequently results in heightened pain, more severe fatigue, greater sleep disturbances, increased anxiety, and a decline in overall psychological well-being, potentially leading to negative outcomes for both the mother and baby . Pregnancy brings a distinct set of difficulties for women with fibromyalgia, as bodily changes, hormonal shifts, and heightened physical requirements may worsen symptoms like generalized pain, tiredness, and sleep problems . These complications can influence the health of both the expectant mother and her baby. Providing nursing care in such cases calls for advanced expertise to effectively manage these complexities and uphold the well-being of both mother and fetus .
Detailed description
Despite increased awareness of the challenges that fibromyalgia presents during pregnancy, evidence-based guidelines for optimal management remain limited, and the use of medications is often restricted due to concerns about fetal safety .Consequently, there is a growing emphasis on non-pharmacological and holistic approaches particularly those delivered by nurses in community settings for their potential to alleviate symptoms and enhance the quality of life for pregnant women with fibromyalgia .
Community-based nursing approaches offer an effective structure for individualized care, focusing on educating pregnant women about managing their symptoms, lowering stress, and making lifestyle adjustments suited to pregnancy . Customized support throughout pregnancy can help control symptoms, lessen anxiety, and contribute to better health outcomes for women with fibromyalgia Also, It offered within the community centering on patient education, strategies for self-management, physical activity and emotional support are designed to be accessible, cost-effective, and responsive to the particular needs of pregnant women . When such interventions are multidisciplinary, incorporating elements like exercise, pain education, nutrition, peer encouragement, and cognitive-behavioral techniques, they have shown to improve patients' satisfaction with care, boost daily functioning, enhance psychological health, and promote healthier coping mechanisms for chronic illnesses like fibromyalgia .
Quality of life (QoL) refers to a broad concept involving physical health, mental wellbeing, and social functioning. For pregnant women with chronic conditions such as fibromyalgia, persistent pain, exhaustion, and psychological stress can greatly diminish QoL. One of the main objectives of nursing interventions is to improve QoL by not just reducing symptoms, but also promoting better daily functioning and emotional strength. Regular assessment of QoL helps nurses tailor care strategies that adapt to the patient's ongoing feedback and changing circumstances.
Nursing professionals play a crucial role in delivering community-based interventions that enhance the quality of life for pregnant women affected by fibromyalgia. Community-based nursing care offers patient-focused, easily accessible strategies customized to meet the specific needs of individuals. This care model integrates health education, promotes self-management skills, encourages physical activity, and provides psychosocial support to enhance overall health outcomes. Nurses facilitate crucial components in managing the specific challenges faced by pregnant women with fibromyalgia through the incorporation of exercise regimens, dietary guidance, and cognitive-behavioral therapy. These nurse-led multidisciplinary interventions have been shown to significantly enhance patients' physical functioning, mood stability, and their overall satisfaction with the care received. By targeting both physical symptoms and psychological well-being, these comprehensive approaches contribute to better health outcomes and improve the overall care experience for this population.
Nursing interventions also promote peer support and active patient involvement, assisting individuals in developing healthier beliefs about pain and strengthening their coping skills. Research shows that community-based care models not only improve daily functioning and mental health but also boost patient satisfaction by addressing the physical, emotional, and social aspects that collectively affect quality of life . Thus , Community-based nursing interventions offer an all-encompassing framework that supports the overall well-being of pregnant women with fibromyalgia. These interventions are integral to multidisciplinary and holistic care models .
Significance of the study:
Fibromyalgia is a prevalent global health issue, affecting approximately 2% to 5% of the population worldwide, with a markedly higher incidence in women, accounting for 80% to 90% of cases . In Egypt, while general data on fibromyalgia prevalence is still developing, specific populations such as university students have shown a prevalence rate as high as 12.4%. When applied to pregnant women, fibromyalgia poses increased challenges due to physiological and hormonal changes during gestation that may exacerbate symptoms . Studies indicate that fibromyalgia is relatively common in pregnant women, with some research reporting prevalence rates up to 37.7%. This higher prevalence underscores the need for targeted nursing interventions and specialized care plans to manage the intensified symptoms and promote better maternal and fetal health outcomes.
This research broadens the understanding of nursing's critical role in managing chronic pain, particularly highlighting how community-based nursing interventions can improve outcomes for pregnant women with fibromyalgia. Such initiatives have the potential to enhance quality of life by addressing key symptoms like pain while also reducing healthcare costs and elevating care standards through personalized, accessible support. The objective of this research is to examine the impact of community-based nursing intervention on the quality of life, symptom management, and overall well-being of this unique population, emphasizing the effectiveness and importance of holistic nursing care approaches in chronic condition management during pregnancy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: community based nursing interventionsThe intervention groups were made up of ten individuals per cohort for a total of Five cohorts. Each cohort Participant flow through the study participated in a 8-week intervention which included once weekly education sessions at Kafr-elshiekh university hospital and twice-weekly exercise sessions. |
| control group | Active comparator | Other: routine careThe control groups were made up of ten individuals per cohort for a total of three cohorts running simultaneously with each intervention group. Participants randomized to the control group received usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- pregnant women diagnosed with fibromyalgia in 1st or 2nd trimester.
- Age ≥18 years
Key exclusion criteria (2 listed)
- those suffering from severe cognitive or mental disorder
- Having major obstetric complications
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 |
|---|---|---|
| community based nursing interventionsThe intervention groups were made up of ten individuals per cohort for a total of Five cohorts. Each cohort Participant flow through the study participated in a 8-week intervention which included once weekly education sessions at Kafr-elshiekh university hospital and twice-weekly exercise sessions. During the first exercise session, participants underwent a one-on-one baseline assessment and were given an individualized exercise program to follow during the twice-weekly exercise sessions. exercise sessions including prenatal yoga, stretching, and aquatic exercises where feasible Tailored intensity based on individual tolerance and obstetric safety guidelines. In relation to education sessions, its component was developed based on evidence-based practice guidelines for fibro myalgia and chronic pain self-management. The 1-hour sessions took place weekly, immediately following one of the exercise sessions. | Behavioural | intervention group |
| routine careusual care for fibromyalgia involves a referral to a rheumatologist. Therefore, patients assigned to the control group were referred to a local rheumatologist for a single, one hour, one-on-one consultation. During this appointment, the patient's history was taken, a physical exam was performed, basic education about fibromyalgia was provided, At the conclusion of the study (i.e., two-month follow-up questionnaires were collected from all participants). | Other | control group |
Primary outcome
Fibromyalgia Quality of Life
Time frame: 1-Baseline Assessment ( T_0- Week 0): Administered immediately after study enrollment and random allocation 2-Mid-Intervention Assessment (T_1 - End of Week 4 / Day 28±3 days) 3-Post-Intervention Follow-Up Assessment (T_2 - End of Week 8 / Day 56±3 day
is 14-item Quality of Life scale that is specific and validated to patients with fibromyalgia
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 16 Sep 2026.
- Individual participant dataSharing planned: No
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.
Farha A El-refaie, PhD principal investigator
faculty of nursing Kafrelsheikh university, Egypt
Amany L Ahmed, PhD study chair
faculty of nursing Kafrelsheikh university, Egypt
Rabab S Hassan study director
faculty of nursing Cairo university, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing community based nursing interventions and routine care in people with Assess the Quality of Life of Pregnant Women With Fibromyalgia, run by farha Ali El-refaie Abdelhamed at 1 site in Egypt.
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 2 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 16 Sep 2026. 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 Egypt. 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?
Fibromyalgia Quality of Life (time frame: 1-Baseline Assessment ( T_0- Week 0): Administered immediately after study enrollment and random allocation 2-Mid-Intervention Assessment (T_1 - End of Week 4 / Day 28±3 days) 3-Post-Intervention Follow-Up Assessment (T_2 - End of Week 8 / Day 56±3 day). 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 16 Sep 2026.