Evidence map›Paper›PMID 35321744›Full record

ArticlePilot and feasibility studies2022

Feasibility and acceptability of somatocognitive therapy in the management of women with provoked localized vestibulodynia-ProLoVe feasibility study.

Mette Bøymo Kaarbø, Kristine Grimen Danielsen, Gro Killi Haugstad, Anne Lise Ording Helgesen, Slawomir Wojniusz

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Pilot and feasibility studies, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04208204 (Somatocognitive Therapy in Treatment of Provoked Vestibulodynia - Process of Change and User Experience), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 28% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04208204 nacompletednot on this map

Somatocognitive Therapy in Treatment of Provoked Vestibulodynia - Process of Change and User Experience

TypeinterventionalSponsorOslo Metropolitan UniversityRan2019 to 2020Enrolled10ConditionsProvoked VestibulodyniaArmssomatocognitive physiotherapy
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 2 countries.

Mette Bøymo KaarbøFaculty of Health Sciences, Department of Physiotherapy, Oslo Metropolitan University, Oslo, Norway. metteboy@oslomet.no.ORCID http://orcid.org/0000-0002-5879-8188
Kristine Grimen DanielsenFaculty of Health Sciences, Department of Physiotherapy, Oslo Metropolitan University, Oslo, Norway.
Gro Killi HaugstadFaculty of Health Sciences, Department of Physiotherapy, Oslo Metropolitan University, Oslo, Norway.
Anne Lise Ording HelgesenDepartment of Obstetrics and Gynecology, Oslo University Hospital, Oslo, Norway.
Slawomir WojniuszFaculty of Health Sciences, Department of Physiotherapy, Oslo Metropolitan University, Oslo, Norway.
Oslo University Hospital · NOOsloMet – Oslo Metropolitan University · NO

Funding

norwegian fund for post-graduate training in physiotherapy 112220oslo metropolitan university 201127
6 · The paper itself

Abstract

backgroundProvoked vestibulodynia (PVD) is a prevalent chronic pain condition especially among young women. Pain is localized to the vulvar vestibule and is provoked by touch or pressure, such as penetrative intercourse. PVD can have profound consequences, adversely affecting a woman's sexual life, relation to her partner, and her psychological health. There is an urgent need for well-designed randomized clinical trials (RCTs) to identify the most effective interventions for this neglected women's health condition.

aimsThe primary aim of this study is to assess the feasibility of undertaking a full-scale RCT of somatocognitive therapy (SCT), a multimodal physiotherapy intervention, for women with PVD. The secondary aim is to evaluate the implementation and acceptability of SCT and its potential treatment effectiveness in PVD. In the full-scale RCT, SCT will be compared to standard PVD treatment.

methodsA multimethod feasibility study with a single-arm before-after trial and qualitative interviews. Ten women with PVD, aged 18-33 were recruited from the Vulva Clinic at Oslo University Hospital. The intervention took place at Oslo Metropolitan University. Participants were assessed at baseline, post-treatment, and the 8-month follow-up with the tampon test and self-report questionnaires. The main feasibility outcomes were evaluation of recruitment rate, adherence to assessment tools, and follow-up rate. The participants' experiences with the primary outcome and the intervention were explored with semi-structured interviews.

resultsTen out of 18 eligible patients were recruited over 11 weeks. None were lost to follow-up. Adherence to self-report questionnaires was excellent. Adherence to tampon tests and to the reporting of treatments was good, whereas adherence to the 14-day diary was poor. No adverse events were reported. The tampon test was suboptimal as a primary outcome. SCT was found to be an acceptable treatment, based on Global Perceived Effect scores and the participants' experiences.

conclusionThe findings suggest that it is feasible to deliver a full-scale RCT of the SCT intervention for women with PVD. Some changes are suggested to optimize the protocol, such as increasing recruitment sites, change of primary outcome measures, and adding a booster session.

trial registrationClinicalTrials.gov NCT04208204 . Retrospectively registered on December 23, 2019.

Indexed as

Feasibility studyProvoked vestibulodyniaSomatocognitive therapyVestibulitisVulvodynia

Identifiers

PMID35321744
PMCPMC8941371
OpenAlexW4225813424

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.