Evidence map›Paper›PMID 33996511›Full record

ArticleInternet interventions2021

Internet-based treatment for vulvodynia (EMBLA) - Study protocol for a randomised controlled study.

Andrea Hess Hess Engström, Merit Kullinger, Izabella Jawad, Susanne Hesselman, Monica Buhrman, Ulf Högberg, Alkistis Skalkidou

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Internet interventions, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02809612 (The EMBLA Project - An Internet-based Intervention as a Supplement to Clinical Management for Vulvodynia Patients), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
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.

NCT02809612 nacompletednot on this map

The EMBLA Project - An Internet-based Intervention as a Supplement to Clinical Management for Vulvodynia Patients

TypeinterventionalSponsorUppsala UniversityRan2016 to 2020Enrolled52ConditionsVulvodyniaArmsInternet-based platform
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Biopsychosocial Approaches for the Management of Female Chronic Pelvic Pain: A Systematic Review.BJOG : an international journal of obstetrics and gynaecology · 2025
    Pooled it
  2. Trial
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

7 authors at 2 institutions in 1 country.

Andrea Hess Hess EngströmCentre for Clinical Research, Västmanland County Hospital, Västerås, Sweden.
Merit KullingerCentre for Clinical Research, Västmanland County Hospital, Västerås, Sweden.
Izabella JawadDepartment of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
Susanne HesselmanDepartment of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
Monica BuhrmanDepartment of Psychology, Division of Clinical Psychology, Uppsala University, Uppsala, Sweden.
Ulf HögbergDepartment of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
Alkistis SkalkidouDepartment of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
Uppsala University · SEVästmanlands sjukhus Västerås · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVulvodynia is defined as vulvar pain for at least 3 months without a clear cause. To the best of our knowledge, there are no trials investigating the effects of internet treatment using CBT (Cognitive behavioural therapy) treatment with Acceptance and Commitment Therapy (ACT) components for women with vulvodynia. The aim of this study is to examine the effects of such a guided internet-based intervention on provoked vulvar pain during the waiting period before clinical treatment.

methodsWe will randomise 52 patients to either guided internet-based intervention with CBT with (ACT) components or no intervention during the waiting period for treatment as usual. Online assessments are conducted at baseline, posttreatment, and at follow-up after 9 months. The primary outcome measure is provoked vulvar pain. Secondary outcomes are depression, anxiety, sexual function, and quality of life. Linear-mixed effect models will be used to assess the effect of the internet-based intervention on vulvar pain, pain acceptance, depression, anxiety, sexual function, and quality of life over time, by applying the intention-to-treat approach. Continuous data will be analysed with general linear models using intention-to-treat and also per protocol approaches to assess the effects of the intervention at different time points. Ordinal and binary data will be analysed with Mann Whitney's test, Fischer's exact test and multivariate logistic regression, respectively. DISCUSSION: As a randomised controlled trial with short- and long-term follow-up points, the EMBLA study intends to provide a novel and better understanding regarding the treatment of vulvodynia and the role of internet-based treatment as a complement to standard care for women suffering from vulvodynia. The effects of vulvodynia on pain, sexual function, quality of life, depression, and anxiety are investigated. The study's results are expected to be of value in the planning of clinical care in the medical area. High dropout rates and technical difficulties associated with using the platform are common in similar studies. TRIAL REGISTRATION NUMBER: NCT02809612.

Indexed as

Acceptance and commitment therapyACT, Acceptance and commitment therapyBAI, Beck Anxiety InventoryCBT, Cognitive Behavioural therapyCPAQ, Chronic Pain Acceptance questionnaireEQ5-D, EuroQol-5-dimension questionnaireESSI, ENRICHD Social Support InstrumentFSDS-R, Female Sexual Distress Scale – RevisedFSFI, Female Sexual Function IndexInternet-basedLOCF, last observation carried forwardMADRS-S, Montgomery-Åsberg Depression Rating ScaleRandomised controlled trialrDAS, Revised Dyadic Adjustment ScaleSWLS, Satisfaction with Life ScaleVulvodynia

Identifiers

PMID33996511
PMCPMC8091887
OpenAlexW3156890468

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.