Effects of a new mattress and pillow for nightly pelvic girdle pain during pregnancy

Effects of a new mattress and pillow as adjunct to standard treatment for nightly pelvic girdle pain in pregnant women: a randomised controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13438272

Enrollment

Registered

2018-04-27

Start date

2018-04-15

Completion date

Unknown

Last updated

2022-01-04

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

Conditions

Pelvic girdle pain (PGP) in pregnant women Pregnancy and Childbirth Pelvic girdle pain

Interventions

An independent specially-trained physiotherapist will assess patients who are eligible and willing to participate in the study. This assessment will include a detailed standardized physical examinatio

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Otherwise healthy 2. Pregnant with singleton fetus and have completed 12-30 gestational weeks 3. Well integrated in the Swedish language 4. Pregnancy-related PGP according to the European Guidelines of diagnosis and treatment of PGP 5. Mean self-reported evening pain intensity of =40 mm (on a VAS) in their baseline diary, i.e. 5-7 days before the screening visit

Exclusion criteria

Exclusion criteria: Other pain conditions

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 15/09/2021: Intensity of nightly pelvic girdle pain measured on a 100-point visual analogue scale (VAS) every morning for the 8 week trial period Previous primary outcome measure as of 18/03/2021: Participant's score of the intensity of their nightly pelvic pain on a 100-point visual analogue scale (VAS), every morning and their present pelvic pain every evening in a diary _____ Previous primary outcome measure: Participant's score of the intensity of their present pelvic pain on a 100-point visual analogue scale (VAS), every morning and every evening in a diary	—

Measure

Time frame

Current primary outcome measure as of 15/09/2021: Intensity of nightly pelvic girdle pain measured on a 100-point visual analogue scale (VAS) every morning for the 8 week trial period Previous primary outcome measure as of 18/03/2021: Participant's score of the intensity of their nightly pelvic pain on a 100-point visual analogue scale (VAS), every morning and their present pelvic pain every evening in a diary _____ Previous primary outcome measure: Participant's score of the intensity of their present pelvic pain on a 100-point visual analogue scale (VAS), every morning and every evening in a diary

—

Secondary

Measure	Time frame
1. The Swedish version of the Pelvic Girdle Questionnaire (PGQ), a questionnaire specific for pelvic girdle pain in pregnancy 2. EuroQoL questionnaire measuring health function and health-related quality of life 3. Pain catastrophizing scale (PCS) a questionnaire measuring thoughts about pain 4. Epworth sleepiness scale (ESS) and subjective sleeping time (number of hours) All questionnaires will be filled at baseline, 4 and 8 weeks. Sleep registration (polysomnography) will be performed during 2-3 nights in 20 participants (10 in each group)	—

Measure

Time frame

1. The Swedish version of the Pelvic Girdle Questionnaire (PGQ), a questionnaire specific for pelvic girdle pain in pregnancy 2. EuroQoL questionnaire measuring health function and health-related quality of life 3. Pain catastrophizing scale (PCS) a questionnaire measuring thoughts about pain 4. Epworth sleepiness scale (ESS) and subjective sleeping time (number of hours) All questionnaires will be filled at baseline, 4 and 8 weeks. Sleep registration (polysomnography) will be performed during 2-3 nights in 20 participants (10 in each group)

—

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026