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Effect of Community-Based Nursing Interventions on Quality of Life in Pregnant Women With Fibromyalgia

Effect of Community-Based Nursing Interventions on Quality of Life in Pregnant Women With Fibromyalgia: A Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07821892
Enrollment
100
Registered
2026-09-16
Start date
2025-10-10
Completion date
2026-08-30
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Assess the Quality of Life of Pregnant Women With Fibromyalgia

Keywords

quality of life, fibromyalgia, pregnant women, Randomized controlled Trials

Brief 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. 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.

Interventions

BEHAVIORALcommunity based nursing interventions

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.

OTHERroutine care

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).

Sponsors

farha Ali El-refaie Abdelhamed
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* pregnant women diagnosed with fibromyalgia in 1st or 2nd trimester. * Age ≥18 years

Exclusion criteria

* those suffering from severe cognitive or mental disorder * Having major obstetric complications

Design outcomes

Primary

MeasureTime frameDescription
Fibromyalgia Quality of Life1-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 dayis 14-item Quality of Life scale that is specific and validated to patients with fibromyalgia

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORFarha A El-refaie, PhD

faculty of nursing Kafrelsheikh university, Egypt

STUDY_CHAIRAmany L Ahmed, PhD

faculty of nursing Kafrelsheikh university, Egypt

STUDY_DIRECTORRabab S Hassan

faculty of nursing Cairo university, Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026